Global Compression Leader SIGVARIS Helps Raise Awareness About Deep Vein Thrombosis and Diabetes During the Month of March
PEACHTREE CITY, GA – Did you know that every year more people die from blood clots than from breast cancer and AIDS combined? In fact, more than two million Americans are affected by blood clots every year. A blood clot also known a Deep Vein Thrombosis (DVT) can break loose and travel to the lungs resulting in a Pulmonary Embolism (PE), an often-fatal condition. That’s why SIGVARIS, the global leader in medical compression stockings and socks, is working to educate people about DVT prevention.
SIGVARIS promotes DVT prevention all year long, and many people are at risk. During the month of March, SIGVARIS, along with the SIGVARIS Diabetic Compression Socks, hopes to raise more awareness about the fact that diabetics are two times more likely to develop blood clots. With Diabetes Alert Day in the month of March along with DVT Awareness Month, SIGVARIS hopes to educate as many people as possible about the dangers of DVT and preventative measures.
Clinical evidence supports the use of graduated compression stockings 15mmHg and higher to help prevent the development of DVT. If the DVT can be prevented, the risk of a Pulmonary Embolism is also prevented, according to the National Heart Lung and Blood Institute. SIGVARIS manufactures graduated compression stockings designed to fit a variety of lifestyles to help with prevention. ?
In addition to those with diabetes, people who: sit for long periods of time (such as when flying or driving); have a period of prolonged bed rest or injury; are pregnant; have cancer; use birth control pills or hormone replacement therapy; have a history of DVT or pulmonary embolism; are overweight; smoke; or are over age 60, are all at an increased risk for developing a DVT, according to the Mayo Clinic. The Mayo Clinic lists additional risk factors on their website.
“SIGVARIS became the global leader in medical compression therapy by caring about the health of the people that wear our products. We wanted to help raise awareness about the dangers of DVT because many people develop blood clots in their legs, including patients with diabetes. Our company’s mission is to help people have healthy legs,” says Judith Brannan, SIGVARIS Medical Affairs & Education Manager.
The Centers for Disease Control and Prevention (CDC) recommends the following tips for DVT prevention:
• Maintain a healthy weight, eat a healthy diet and don’t smoke
• Exercise regularly
• Drink plenty of water and avoid alcohol or caffeine
• Wear loose-fitting clothes
• When traveling or sitting for more than four hours get up and walk around every few hours and exercise legs while sitting.
• Move around as soon as possible after surgery, illness or injury
• Those at risk for DVT should talk to their doctor about graduated compression stockings and medication (anticoagulants) to prevent or treat DVT
To learn more about DVT prevention, check out these educational resources: http://www.sigvarisus.com, www.vdf.org, www.phlebology.org, www.cdc.gov, and www.stoptheclot.org.
Global Compression Leader SIGVARIS Announces New Addition for the Company’s Most Extensive
Medical Line – The Select Comfort Series
PEACHTREE CITY, GA – SIGVARIS’ most extensive medical line,
The Select Comfort Series, is gaining new legs as the line expands its product offering to include petite and plus size products.
On March 5, the petite products will be available in calf-length, thigh-highs and pantyhose for women with small and medium ankle sizes and a petite stature. At the same time, the plus size pantyhose will be available for plus size women and men, as well as expectant mothers with small, medium and large ankle sizes.
The Select Comfort Series is available in several open and closed toe styles. The products are available in 20-30mmHg and 30-40mmHg compression levels and feature a unique two-way stretch that makes this product very easy to don and remove. The women’s products are available in Natural, Suntan, Crispa and Black shades.
The Select Comfort Series also features products for men. The fashionable ribbed design gives men the option of wearing calflength or thigh-high products that look similar to regular socks with all the health benefits of medical compression stockings. Men’s products are available in Dark Khaki and Black. Non-ribbed open toe products for men are also available in Crispa.
Products with graduated compression are tightest at the ankle and feature less compression going up the leg. These products help fight the force of gravity and improve circulation. Wearing products with graduated compression may help prevent a Deep Vein Thrombosis, as well as help prevent venous disorders such as chronic venous insufficiency. The Vascular Disease Foundation estimates that at least 20 to 25 million Americans suffer from varicose veins.
People who experience heavy, tired or aching legs, cramps, swollen ankles, spider veins or varicose veins should talk to their doctor about graduated compression stockings for relief. Some of the biggest risk factors for venous problems include long distance travel, being over age 40, pregnancy, obesity, a sedentary lifestyle, surgery or trauma, heredity, or use of hormone medications.
Learn more about leg health and benefits of graduated compression socks and hosiery at http://www.sigvarisus.com. About SIGVARIS
SIGVARIS® North America is part of an internationally active medical device group headquartered in Winterthur, Switzerland that focuses on the development, production and distribution of medical compression garments, including hosiery and socks. With distribution in more than 50 countries on six continents, SIGVARIS is recognized as a global industry leader in the area of compression therapy for the management of chronic venous disorders. Our US manufacturing plant is located in Peachtree City, GA. For more information, please visit http://www.sigvarisus.com. SIGVARIS, LIFE FOR LEGS and the leg icon are trademarks of SIGVARIS AG in Switzerland and are registered in many countries worldwide.
BioMedix™ PADnet™ Surpasses One Half Million Completed Tests (this has two Images)
SAINT PAUL, MN —BioMedix announced today that over 500,000 tests for Peripheral Artery Disease (P.A.D.) have been completed using its flagship product, the PADnet vascular diagnostic device. The 500,000th PADnet test was completed in a cardiology office in Brooklyn, New York on February 9th, 2012. PADnet is a user-friendly system that uses automated means to detect P.A.D. and Chronic Venous Insufficiency (CVI). In just 15 to 20 minutes during an office visit, the non-invasive PADnet test helps identify obstructive disease and determine whether medical or surgical treatment is necessary. The PADnet platform allows remotely connected specialists (PADnet Readers) to review tests and send the interpretations back to PADnet test sites. This care model saves time and travel for the patient and reinforces collaborative relationships between providers.
P.A.D. is a serious condition in which clogged or narrowed arteries cause poor circulation. It occurs most often in the lower extremities, causing decreased blood flow to the legs and feet. Just like buildup in the heart, clogged arteries in the lower extremities can cause stroke or heart attack. An early diagnosis of P.A.D. can help save limbs and improve the quality of life for patients suffering from this condition.
“PADnet technology overcomes many issues associated with the use of conventional tests to detect P.A.D., enabling greater collaboration and access to testing in a variety of settings,” said David Lerner, BioMedix VP of Research & Development and CTO, “We expect the testing rates to increase considerably in the future as the PADnet network and awareness of P.A.D. continue to grow.”
First introduced in 2004, PADnet has since been awarded the Frost & Sullivan Award for Product Leadership* and the APMA Seal of Approval, and has been recognized in numerous trade magazines, news outlets and publications. Today, approximately 3,500 PADnet systems are in use in physician offices and hospitals across the United States.
“We are proud to see PADnet reach this milestone and are encouraged by the favorable clinical and cost optimization trends we have seen over the life of the product,” said John Romans, BioMedix President & CEO, “This accomplishment could not have been realized without our valued clients—physicians and specialists who have taken steps to collaborate in the diagnosis, treatment and management of this dangerous, yet underdiagnosed disease.”
TRAKnet™ PM – DPM Edition Leads Podiatry EHRs in Meaningful Use Attestation
ST. PAUL, MN —According to data released by DATA.gov and the U.S. Department of Health and Human Services, BioMedix™ TRAKnet PM – DPM Edition is the number one Electronic Health Record (EHR) for Meaningful Use attestation among podiatric physicians.
TRAKnet PM – DPM Edition, an ONC-ATCB 2011/2012 Certified Complete EHR* and practice management system designed exclusively for podiatry, has been used for more than 30% of successful attestations by podiatric physicians. With nearly 600 successful attestations by TRAKnet PM – DPM Edition users already on record, the system accounts for more than double the successful attestations of the next leading competitor. In fact, the number of attestations completed by TRAKnet PM – DPM Edition users is greater than those completed with the next four podiatryspecific EHRs combined.
TRAKnet PM - DPM Edition was the first podiatry-specific EHR to earn Complete EHR certification and the first EHR to receive the APMA Seal of Acceptance. The program is equipped with a commercial drug database, clinical decision support and other features necessary for Meaningful Use and to ensure eligibility for government incentives. The system provides a Meaningful Use report, which shows progress towards completion of Core and Menu set objectives, as well as a Quality Measures report, which tracks Physician Quality Reporting System (PQRS) measures, helping providers go beyond Meaningful Use to meet additional incentive requirements.
BioMedix™ Supports the Vascular Disease Foundation, Joins Corporate Roundtable
VIENNA, VA –The Vascular Disease Foundation (VDF), a national non-profit organization, today announced that BioMedix, the company that provides the only integrated suite of hardware, software and online services designed to cost-effectively detect Peripheral Artery Disease (PAD) and Chronic Venous Insufficiency (CVI), has become a member of its Corporate Roundtable. The mission of the Corporate Roundtable is to help increase public awareness about vascular disease while serving as a forum for dialogue between the industry and the nation’s most recognized thought leaders in the vascular arena.
BioMedix’s contribution will help support the VDF’s key initiatives including the Venous Disease Coalition and P.A.D. Coalition, as well as media and public relations campaigns to elevate national awareness of vascular disease. Additionally, VDF will continue distributing free patient brochures about vascular disease to the general public and medical facilities across the country. The next meeting is scheduled for Friday, March 23, 2012 in Tysons Corner, VA.
“With BioMedix as our partner, the Vascular Disease Foundation will have a stronger ability to help reduce the mortality and morbidity caused by vascular disease through awareness initiatives,” said Rob McLafferty, M.D., president of VDF’s Board of Directors. “Working together, we will identify new ways of educating Americans about the signs and symptoms of vascular disease. Our goal is to enable a faster diagnosis and effective rehabilitation for those with artery and venous disease, hopefully giving people a better quality of life and increasing their longevity. We are grateful to BioMedix for their participation and support.”
“BioMedix has long been dedicated to prolonging and enhancing life through the early detection of vascular disease,” John Romans, President & CEO of BioMedix said, “We are proud to partner with the VDF through their national Corporate Roundtable as part of our shared mission to elevate awareness and reduce the impact of these highly prevalent, yet under diagnosed conditions.”
About BioMedix
BioMedix is a leader in software, products and services that connect healthcare providers to create a continuum of collaborative care. BioMedix supports connected care communities with integrated solutions designed to cost-effectively exchange information, manage disease and improve patient outcomes. For more information about the full suite of BioMedix products, call 877-854-0014 or visit www.BioMedix.com.
About the Vascular Disease Foundation
Founded in 1998, the Vascular Disease Foundation® (www.vdf. org) is the nation’s leading non-profit information and education resource on the diagnosis and management of vascular diseases, which affects more than 54 million Americans. Its mission is to reduce death and disability caused by vascular diseases while improving the overall vascular health for Americans. Through its magazine, website, brochures, fliers, meetings, and public service announcements, the VDF has served more than 13,620,000 individuals in 30 states plus Canada. The VDF is headquartered in Vienna, VA. For additional information, call 888-833-4463.
Study May Prove PTSD is a Medical, Not Psychological, Condition (images)
A Chicago physician is recruiting veterans with PTSD for a study of a medical treatment that erases symptoms in 30 minutes. Chicago, IL—With $82,000 in funding from the state of Illinois, Dr. Eugene Lipov (www.ChicagoMedicalInnovations.org), author of Exit Strategy for Post-Traumatic Stress Disorder, plans to treat 10 patients and follow up with biological marker tests that would help prove his theory that PTSD is a medical, not a psychological, condition. He’s seeking corporate donations to broaden the study in order to hasten the Veterans Administration’s acceptance of the procedure, which has been used to treat 95 patients.
“The Veterans Administration’s treatment for PTSD involves intensive psychological therapy and psychotropic drugs that works only about half the time and can take months or years,” Lipov says. “My treatment, stellate ganglion block (SGB), involves two injections and works very quickly. In 80 to 85 percent of patients, it completely erases symptoms.”
Lipov has treated 50 patients with SGB, an injection of anesthesia into a cluster of nerves in the neck. His success stories date back to his first patient, who remains symptom-free after three years. Another 45 or so veterans have undergone the treatment at four military institutions, including a small study still underway at the Naval Medical Center San Diego.
He theorizes that SGB works because it reduces excessive levels of cortisol, nerve growth factor and norepinephrine in the brain, all stimulated as an organic response to stress.
“This study will be the first that includes checking for posttreatment biomarkers,” Lipov says. “I I can show there’s a biological change, that the treatment’s success isn’t just a placebo effect, I can get more acceptance. Right now, part of the problem is credulity – people can’t believe there’s such a simple solution to a complex problem.”
Treating PTSD with SGB is a new application for a procedure that’s been safely used to treat other conditions since 1925. Lipov has FDA approval for its use for PTSD and recently it was approved for experimental studies by the Institutional Review Board.
But despite congressional support, he has been unable to secure federal funding for a large study that would hasten the treatment’s acceptance by the Veterans Administration. So he’s seeking private and corporate donors to match Illinois’ contribution to his nonprofit, Chicago Medical Innovations, so he can expand the biomarker study. People who buy his book Exit Strategy, about the latest PTSD developments, also help fund veterans’ treatments; Lipov donates $5 from each book sale toward the two $1,000 injections.
“The more money I raise, the more patients I can treat, and the more veterans who get better, the more I can publish the results,” Lipov said. “Basically, the more impressive the numbers, the more lives are saved.”
An estimated 300,000 veterans of Iraq and Afghanistan suffered post-traumatic stress disorder or major depression, according to a Rand Corp. report. The debilitating condition is characterized by outbursts of rage, terrifying flashbacks, nightmares, anxiety and other issues that lead to substance abuse, violent crimes, joblessness and homelessness.
About Dr. Eugene Lipov
Dr. Lipov graduated from Feinberg School of Medicine at Northwestern University and completed two-year residencies in surgery and anesthesiology before receiving advanced training in pain management at Rush University Medical Center, where he worked as an assistant professor of pain management. Today he is the medical director of Advanced Pain Centers in Hoffman Estates, Ill. He has published research articles in several medical journals.
AngioDynamics Receives FDA Clearance for NeverTouch Direct™ Procedure Kit to be used with the VenaCure EVLT® System
NeverTouch Direct kit allows physicians to treat varicose veins with fewer procedure steps
ALBANY, NY – AngioDynamics, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced the U.S. Food and Drug Administration has granted 510(k) clearance for its NeverTouch Direct™ Procedure Kit for use with the Company’s VenaCure EVLT® Laser Vein Ablation System. The NeverTouch Direct kit offers physicians the ability to treat varicose veins with fewer procedure steps – by eliminating the need for a long guide wire or guiding sheath – while continuing to deliver to patients less pain and bruising compared to bare-tip fibers.
“NeverTouch Direct and the sheathless fiber option further expands the physician’s ability to tailor treatment to each individual patient, and avoid one-size-fits-all approaches that limit the physician’s ability to exercise their clinical judgment,” said Alan Panzer, Senior Vice President and General Manager for AngioDynamics. “Taken together with the advantages delivered by our new VenaCure® 1470 laser, and the new NeverTouch® 90cm fiber, AngioDynamics remains the clear choice for clinicians who demand tools that take advantage of their full range of skill and experience.”
The NeverTouch Direct kit, expected to launch in summer 2012, is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.
About AngioDynamics
AngioDynamics, Inc. is a leading provider of innovative, minimally invasive medical devices used by professional healthcare providers for vascular access, surgery, peripheral vascular disease and oncology. AngioDynamics’ diverse product lines include marketleading ablation systems, vascular access products, angiographic products and accessories, angioplasty products, drainage products, thrombolytic products and venous products. More information is available at www.AngioDynamics.com.
Five Oral Presentations on Clinical Experience With NanoKnife® System Featured at Society of Interventional Radiology Conference
ALBANY, NY--, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced oral presentations on NanoKnife® System clinical experience took place at the Society of Interventional Radiology (SIR) 2012 Annual Scientific Meeting,March 24-29, 2012, in San Francisco, Calif.
An oral presentation titled “A prospective, multicenter phase II clinical trial using irreversible electroporation for the treatment of early stage HCC,” was given March 28, 2012. The authors of this Company-sponsored European study included Professors Riccardo Lencioni and Laura Crocetti of the University of Pisa, Pisa, Italy; Francesco Izzo of Istituto Nazionale Tumori -- Fondazione Pascale, Naples, Italy; Valerie Vilgrain and Mohamed Abdel-Rehim of Hopital Beaujon, Paris, France; Jens Ricke and Maciej Pech of Universitatsklinikum Magdeburg AoR, Klinik fur Radiologie und Nuklearmedizin, Magdeburg, Germany; Jordi Bruix and Luis Bianchi of the Hospital Clinic i Provincial de Barcelona (BCLC), Barcelona, Spain.
The trial is a phase II prospective, multicenter clinical study to evaluate the efficacy and safety of the NanoKnife System as a firstline treatment for early-stage hepatocellular carcinoma (HCC), the most common form of liver cancer. It is registered with www. ClinicalTrials.gov as number NCT01078415.
The following retrospective data analyses also were presented at SIR’s 2012 Annual Scientific Meeting.
An oral presentation titled “Downstaging locally advanced pancreatic adenocarcinoma (LAPC) with vascular encasement using percutaneous irreversible electroporation (IRE),” was given March 27 2012. The authors included Doctors Govindarajan Narayanan, Geetika Arora, Katuska Barbery, Tatiana Froud, Alan Livingstone, Dido Franceschi, Peter Hosein, Caio Rocha Lima, and Jose Yrizarry of the University of Miami, Miami, Fla.
Eight patients with biopsy-proven pancreatic cancer underwent percutaneous ablation of pancreatic tumors using the NanoKnife System. Imaging demonstrated intact veins in all patients’ treatment zones immediately, and 24-hours, after the procedure. Complications included spontaneous pneumothorax during anesthesia in one case and pancreatitis in one case. Both recovered completely. No mortalities occurred within 30 days. Follow up was conducted with each patient in the months after the procedure. This analysis also was the subject of a press release issued by SIR regarding the conference, as well as a press event hosted by the organization on March 26, 2012.
An oral presentation titled “Vessel patency post Irreversible Electroporation ablation -- a 15 month follow up,” was given March 26, 2012. The authors included Doctors Govindarajan Narayanan, Geetika Arora, Jose Yrizarry, David Quintana, Umamaheshwari Mukkamalla, Katuska Barbery and Peter Hosein of the University of Miami, Miami, Fla.
Ablation using the NanoKnife® System was performed in 79 procedures on 56 patients between January 2010 and June 2011. Overall, narrowing or thrombosis occurred in three out of 84 vessels in close proximity to the treatment zone.
An oral presentation titled “Percutaneous Irreversible Electroporation of Surgically Unresectable Pancreatic Carcinoma: Single Center Safety Experience,” was given March 26, 2012. The authors included Doctors Sandeep Bagla, Dimitrios Papadouris, and Arina van Breda, of INOVA Alexandria Hospital, Springfield, Va.
In this clinical experience, four consecutive patients with surgically unresectable pancreatic carcinoma received seven ablations of five tumors. No mortalities occurred within 30 days. No episodes of intra-operative arrhythmia occurred. Intra-operative transient hypertension occurred with all treatments. No patients had prolonged hypertension after completion of the procedure with the NanoKnife System. There were no incidents of hemorrhage, infection, pancreatic fistula, or bowel injury. One treatment was complicated by partial splenic infarction, which required no treatment. No patients required analgesics on discharge.
An oral presentation titled “Percutaneous irreversible electroporation in the treatment of hepatocellular carcinoma (HCC) and metastatic colorectal cancer (mCRC) to the liver,” was given March 26, 2012. The authors included Doctors Govindarajan Narayanan, Katuska Barbery, Jose Yrizarry, and Peter Hosein of the University of Miami, Miami, Fla.
Forty-nine patients underwent percutaneous ablation of unresectable HCC and mCRC liver tumors using the NanoKnife System. A total of 76 lesions were treated in 62 sessions. After a procedure with the system, 20 patients had a complete response, 19 had a partial response and one had stable disease as their best response. Two of the HCC patients were transplanted. The Kaplan-Meier estimated average progression free survival was 11.3 months for all patients, 11.6 for HCC patients, and 10.4 months for mCRC patients. Six patients experienced complications during the procedure of the following types: pneumothorax, pleural effusion and atrial flutter during anesthesia. All patients recovered fully from these complications. One patient died within one month of a procedure with the NanoKnife System due to disease progression.
In the United States, NanoKnife has been cleared by the FDA for use in the surgical ablation of soft tissue. NanoKnife has not been cleared for the treatment or therapy of a specific disease or condition.
About AngioDynamics
AngioDynamics, Inc. is a leading provider of innovative, minimally invasive medical devices used by professional healthcare providers for vascular access, surgery, peripheral vascular disease and oncology. AngioDynamics’ diverse product lines include market-leading ablation systems, vascular access products, angiographic products and accessories, angioplasty products, drainage products, thrombolytic products and venous products. More information is available at www.AngioDynamics.com.
Investigator-Sponsored Study of PLC's RenalGuard® Demonstrates Reduced Mortality
and Fewer Adverse Events Than Alternatives
First Longer-Term Study Presented at ACC 2012 Reports Reduced Mortality and Reduced Adverse Events in Severe Renal Failure Patients Treated with RenalGuard compared to Hemofiltration and Sodium Bicarbonate
MILFORD, MA -- PLC Systems Inc., a company focused on innovative medical device technologies, today announced that results from a new investigator-sponsored clinical trial of RenalGuard® in Italy -- the first to follow longer-term outcomes -- were presented at the annual conference of the American College of Cardiology (ACC.12), March 24 - 27, 2012, Chicago, Illinois. These results showed that RenalGuard is superior to two alternative methods at reducing rates of mortality, in-hospital adverse events, the need for dialysis, major adverse cardiac events (MACE) and Contrast- Induced Nephropathy (CIN) in high-risk patients undergoing cardiac catheterizations using iodinated contrast.
The investigators compared the use of three different CIN prevention methodologies in three consecutive blocks of patients: hydration with Sodium Bicarbonate plus N-acetylcysteine (Hy), continuous veno-venous hemofiltration (CVVH), and PLC's RenalGuard System™, in 100 patients with severe renal failure who underwent elective percutaneous coronary and/or peripheral vascular interventions. The results provided evidence that RenalGuard can reduce mortality and adverse events at three different points: in hospital, one month following and six months later, compared to the alternatives.
The study was led by Dr. Giuseppe Sangiorgi, who was also an investigator in the REMEDIAL II study, the randomized multicenter trial that established the superiority of RenalGuard to standard therapy in reducing the rates of CIN in at-risk patients. "Results from this new study, when combined with the results of REMEDIAL II and MYTHOS, provide strong support for the use of RenalGuard in at-risk patients. Based on these results, we use RenalGuard for our at-risk patients, and I encourage my colleagues to do the same," said Dr. Sangiorgi.
Mark R. Tauscher, President and Chief Executive Officer of PLC Systems, said, "We are delighted that the first study to look at the long-term impact of RenalGuard Therapy® on patient outcomes found these positive results. The MYTHOS and REMEDIAL II studies established that RenalGuard Therapy reduces the rates of CIN in at-risk patients. These new findings build on that data and demonstrate that reductions in CIN rates can translate into significant improvements in patients' short and longer-term outcomes, most critically in reducing patient mortality. Although it was a small study, we believe these results offer continued support for our efforts to drive sales of RenalGuard in markets where it is available. Our U.S. pivotal trial, which is currently underway, will also evaluate longer-term outcomes, so that we will have the opportunity to determine from the larger patient population in the U.S. pivotal trial whether we can replicate the conclusions from this 100 patient study."
In this study, which was undertaken by a group of cardiologists at the University of Medona in Italy under the leadership of Dr. Sangiorgi, the investigators reported that none of the RenalGuardtreated patients required dialysis in the hospital as compared to 20% of those treated with CVVH and 6% of hydration patients. Only 6% of the RenalGuard-treated patients experienced inhospital adverse events versus 37% for CVVH-treated patients and 12% for Hy-treated patients. More importantly, six months after their treatment, none of the RenalGuard-treated patients had died, whereas patients treated with CVVH had a mortality rate of 26% and patients who received sodium bicarbonate therapy had a mortality rate of 6%. Although this aspect of the results was not sufficiently powered to be statistically significant, the researchers reported that CIN occurred less frequently (15%) in RenalGuard treated patients, versus 31% and 25% in patients in the other two groups respectively.
The findings from this study have been published in ACC.12 supplement to The Journal of the American College of Cardiology at the following link ( http://www.sciencedirect.com/science/article/pii/ S0735109712600977 ) andcan also be accessed by visiting PLC's website ( www.plcmed.com ).
Another study released at ACC last week also demonstrated that CIN remains a significant and growing problem for patients undergoing percutaneous coronary interventions (PCI's) in the U.S. A team of researchers, including cardiologists at major healthcare institutions in the U.S., supported by Cardiac Data Solutions, examined the database of all Medicare beneficiaries receiving PCI's from 2008 to 2010. They found that the rate of CIN in patients undergoing PCI increased between 2009 and 2010 and the need for dialysis increased as well. The investigators concluded that this increase in renal complications warrants increased focus on reducing renal damage associated with CIN.
About PLC Systems
PLC Systems Inc., headquartered in Milford, Mass., is a medical device company focused on innovative technologies for the cardiac and vascular markets. PLC's newest product, RenalGuard, has been developed to help prevent the onset of Contrast-Induced Nephropathy (CIN) in at-risk patients undergoing certain cardiac and vascular imaging procedures. The Product is CE-marked and is being marketed in Europe and selected countries around the world. Two investigator-sponsored European studies have demonstrated RenalGuard's effectiveness at preventing CIN. RenalGuard is being studied in a pivotal trial in the U.S., as required for approval by FDA.
EKOS Corporation Announces Two More Pulmonary Embolism Clinical Studies
SEATTLE I and II Clinical Studies Will Further Establish the Safety and Efficacy of Ultrasound Accelerated Thrombolysis for Treatment of Pulmonary Embolism
BOTHELL, WA: EKOS Corporation today announced the launch of two more landmark clinical studies named SEATTLE I & II, intended to further establish the safety and efficacy of its unique, ultrasound-accelerated thrombolysis in treating patients with life-threatening pulmonary embolism (PE).
The SEATTLE I & II studies are, respectively, a multi-center, retrospective analysis of PE patients treated with EKOS, and a multi-center, prospective study of both massive and submassive PE patients treated with EKOS. The principal investigator for the SEATTLE series is Samuel Z. Goldhaber, MD, Professor of Medicine at HarvardMedical School, and Director of the Brigham And Women’s Hospital Venous Thromboembolism Research Group. The first patients to be enrolled in SEATTLE II are expected in June 2012 with complete enrollment from up to 25 study sites expected by mid 2013.
Collection of retrospective data for the SEATTLE I study has already begun at nine international sites and should be completed in Q4 2012.
EKOS launched its first PE study, ULTIMA, in 2010 with lead principal investigator Dr. Nils Kucher of Bern University Hospital (Switzerland). ULTIMA is an international, multi- center, randomized, controlled study comparing submassive PE patients treated with EKOS to standard-of-care anticoagulation. This study is more than half enrolled and is expected to be completed in 2013.
“When completed, the ULTIMA and SEATTLE studies will represent the largest and most rigorous medical device studies in medical history for the treatment of pulmonary embolism,” said Dr. Goldhaber.
Robert W. Hubert, President/CEO states, “With the staggering statistics of deaths and morbidity associated with PE, these trials are essential in fully defining the role that EKOS will play in addressing this major unmet medical need.”
The U.S. Surgeon General reports over 600,000 patients are stricken with this disease in the U.S. alone resulting in up to 180,000 deaths annually, more than AIDS, breast cancer and auto accidents combined. A PE is caused when a large blood clot, usually from a vein in the upper leg, or pelvic veins, breaks away and lodges in the lungs. The resulting strain on the heart, which must push blood past the obstruction, causes symptoms similar to a heart attack and can result in death or permanent disability. The use of blood thinners can reduce the risk of more clots developing; however blood thinners do not remove the existing obstruction.
The patented EKOS EkoSonic® Endovascular delivery catheters are designed to condition the clot for more rapid absorption of clot busting drugs; a critical factor when every minute counts. The EKOS system was cleared by the US Food and Drug Administration in 2005 and since then has been used by physicians worldwide to treat blood clots in arteries and veins throughout the body, especially in the arms and legs.
The FDA further cleared the device to be used in the pulmonary artery in 2008. Shortly thereafter, users in the US and Europe began reporting success in treating patients with PE using the EKOS device. EKOS received the CE Mark to treat massive and submassive PE in January 2010. “Since 2009, over 600 PE cases have been treated with EKOS,” concluded Robert W. Hubert, President/CEO.
The most critical patients with major lung obstructions are those with massive PE who have deteriorated into cardiogenic shock and are close to death; less dramatic but still potentially life-threatening are those who are stable but still show clinical signs of cardiac dysfunction. These are sometimes referred to as submassive PEs. These two groups account for 5% and 40% of all PE patients, respectively. Multiple international medical journals report that patients who leave the hospital with residual cardiac strain from a remaining thrombus occlusion are at increased risk for long-term, permanent heart damage or even death.
The timeliness of these studies was highlighted in a featured syndicated television broadcast, The Doctors, May 2, 2012 on the CBS network. Dr. Tod Engelhardt, a cardiothoracic surgeon from East Jefferson General Hospital (Metairie, LA) featured in the broadcast, described his pioneering use of EKOS to treat 42 PE patients. The published summary on his first 24 patients can be found in the May 2011 Thrombosis Research journal (128 (2011) 149–154).
About EKOS Corporation: EKOS Corporation pioneered the development and clinical application of ultrasound infusion technologies in medicine, introducing its first system for the treatment of vascular thrombosis in 2005. Today, interventionalradiologists, cardiologists, cardiothoracic and vascular surgeons at leading institutions around the world use the EKOS EkoSonic® Endovascular System to provide faster, safer and more complete dissolution of thrombus. www.ekoscorp.com
