News And New Releases

AngioDynamics Expands VenaCure EVLT® System for Varicose Veins with Longer 90 cm Kit

ALBANY , NY —AngioDynamics (NA SDA Q:ANGO ) announced the launch of the new 90 cm NeverTouch® procedure kit featuring a longer TRE -Sheath® introducer to gain vascular access above the ankle for the treatment of varicose veins that extend below the knee. The new kit complements existing kit lengths of 25 cm, 45 cm and 65 cm, and rounds out the NeverTouch fiber product offering.

“The NeverTouch fiber enhances the patient experience by reducing post-operative pain and bruising, and is now available in a 90 cm length to further enhance the physician’s experience and increase the product’s versatility,” said Tom Kupec, Vice President of Marketing for AngioDynamics. “Our entire NeverTouch product offering now gives physicians the ability to tailor treatment to each patient’s needs while still benefiting from the unique benefits of our gold-tip fiber.”

Together with the 25 cm, 45 cm and 65 cm kit lengths, the new kit continues to build on the core benefits of the NeverTouch gold-tip laser fiber and VenaCure EV LT® system. The primary innovation in the NeverTouch tip is a glass weld at the distal tip of a 600 um fiber. The weld results in an effective fiber diameter of 905 ums and lowers the actual power density at the tip by 56% from that of a standard bare-tip 600 um fiber. This provides a homogeneous ablation with less focal charring of the vein wall that is typically seen with bare-tip fibers. The gold jacketed tip also maximizes tip visibility under ultrasound and eliminates chances of inadvertent fiber tip contact with the vein wall, further improving safety and patient comfort.

AngioDynamics’ VenaCure EV LT endovenous laser vein treatment offers patients a proven, minimally-invasive choice for treating the source of their varicose veins and provides them with immediate recovery and a return to normal daily routines. The VenaCure EV LT system includes the Delta 810nm laser, a choice of procedure kits, procedure accessories, a tumescent delivery system, practice and market development resources, and more. The NeverTouch gold-tip laser fiber, an integral part of AngioDynamics’ advanced varicose vein treatment, establishes a new standard for patient comfort, visibility and ease of use.

For more information on the VenaCure EVLT system, visit www.VenaCure-EVLT.com.

Avoid Medicare Reimbursement Cuts with Acentec’s E-Prescribing Software

IRVINE , CA — For medical facilities who don’t yet use e-prescribing software, many will face Medicare reimbursement cuts if they do not start using it by June 2011, according to the Medicare Improvements for Patients and Providers Act (MI PPA). Because Medicare is such a large source of income for many medical clinics, this penalty will deeply affect many offices.

To avoid getting Medicare payment cuts in 2012 and 2013, medical offices must use e-prescribing for at least 10 patients by June 30, 2011, and 25 patients by the end of 2011. Those that do not meet these requirements will receive a Medicare penalty of 1% in 2012 and 1.5% in 2013.

Not all e-RX systems qualify for this regulation. Acentec, provider of electronic medical records and e-prescribing systems, uses Medinformatix’s e-RX module, which does qualify for this act. While it’s not required to get the e-RX module in conjunction with electronic medical records, given the economic stimulus for converting to EMR along with the e-prescribing component can save your facility thousands.

“Many medical offices may not be aware of MI PPA, and will suffer for the next two years if they do not comply,” said Jeff Mongelli, President of Acentec, “It’s our goal to educate people about what they need in an e-prescribing system.”

To ensure your Medicare reimbursements don’t get cut for the next two years, ensure that your e-RX solution meets the requirements in the MI PPA documentation. Also start now to ensure that you are up and running in time to service a minimum of 10 patients through your e-prescribing solution by June 30, and 25 by year end. Acentec can get you up and running with the hosted version For more information on Acentec’s e-RX platform, visit www.acentec.com or call 800-970-0402.

VenX Announces 510(k) Clearance for Revolution™ Device

NA SHVI LLE, TN — VenX, LLC, a medical device company dedicated to revolutionizing the treatment of spider and reticular veins, is pleased to announce that the company has received 510(k) clearance from the FDA for its VenX Revolution™ device.

Citing the common limitations of the current treatments available to treat spider and reticular veins, the founders of VenX set out to develop novel systems to treat these common vein disorders. Dr. Edward Boyle and Dr. Andrew Jones, experienced vein doctors at Inovia Vein Specialty Center in Bend, Oregon, teamed up with clinical experts and design specialists from around the world and developed a devicethat they termed the VenX Revolution™ to treat and eliminate spider and reticular veins in a transdermal fashion.

“We are very excited about receiving FDA clearance for the VenX Revolution™ and being one step closer to bringing this revolutionary spider and reticular vein treatment to market. We are currently completing our final clinical trials and working towards launching the product,” said Navroze Mehta, President and CEO of VenX. For more information, please visit www.venxmedical.com.

Vascular Solutions Introduces the OptiSeal™ Valved Peelable Introducer

MINNEA POLIS, MN —Vascular Solutions, Inc. announces the immediate availability of the OptiSeal™ valved peelable introducer, a unique, ergonomic peel-away introducer sheath to facilitate placement of device leads and catheters in thevenous system.

The OptiSeal combines a sheath constructed from PTFE with a proprietary valve for optimal insertion and sealing, preserving the integrity of the lead or catheter. The locking hub prevents separation of the sheath and dilator during insertion into the vessel, and a smooth sheath-to-dilator transition provides atraumatic vessel access. The OptiSeal system advances safety and simplicity, with symmetric, ergonomically designed handles allowing for a smooth, unidirectional crack and peel, designed to reduce risk of air embolism as well as limit the clinician’s exposure to blood-borne pathogens. Each OptiSeal system contains a 13cm peel-away valved introducer sheath with a locking dilator, a 60cm 0.035” guidewire, an 18 gauge needle, and a 12cc syringe. OptiSeal introducers are available in seven sizes, from 6F to 12F, color coded by French size for easy identification.

The OptiSeal valved peelable introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system, and is available in the United States through Vascular Solutions, Inc.

Vascular Solutions, Inc. is an innovative medical device company that focuses on developing unique clinical solutions for coronary and peripheral vascular procedures. The company’s product line consists of over 50 products in three categories: catheter products, hemostat products and vein products. For more information, visit www.vascularsolutions.com.

New Encircle Compression Therapy wins Medical Design Excellence Award

AUCKLAND , NZ —A new range of merino compression stockings developed in New Zealand by Locus Research and The Merino Company (TMC ) has scored a major international win with a Medical Design Excellence Award (MDEA ) announced in the United States. The MDEA awards recognize achievements of groundbreaking innovations that “change the face of healthcare”.

‘Encircle Compression Therapy’ (Encircle) is a range of compression products clinically proven to help in safely preventing and treating Chronic Venous Insufficiencies. Encircle significantlyadvances patient care by making compression therapy easier to specify, apply, and manage during use while lowering the overall cost of treatment.

Encircle garments are composed of an innovative weft knittedmedical textile made of merino wool and  polyester that create a ‘skin micro-environment’ for effective regulation of the skin. Merino wool is a natural fiber comprised of keratin, a fibrous protein also found in the outer layer of human skin - making it ideal for second skin compression applications. Merino also has unique and naturally occurring moisture absorbent, antibacterial, antimicrobial and odor-inhibiting properties, which makes Encircle very comfortable.

The Encircle team has also developed a method of specification linked to the product that streamlines diagnosis, making prescription easier and accurate, and a pressure adjustment mechanism built into the garment to allow patients to temporarily increase or decrease pressure once applied.

Encircle has medical research and clinical claims to back up its effectiveness with random controlled trials conducted by Professor Richard Beasley and his team at the Medical Research Institute of New Zealand.

For further information please visit www.encirclemedicaldevices.com.

GORE® Hybrid Vascular Graft Commercially Available in the United States

Optimal outflow with expanded treatment options for dialysis access patients, more than 130 successful implants

FLAG STA FF, AZ —W. L. Gore & Associates (Gore) announced commercial availability in the US of the GORE ® Hybrid Vascular Graft. The Gore device expands treatment options and improves blood flow for dialysis access patients with end-stage renal disease (ESRD ). More than 130 dialysis access patients have been successfully treated with the GORE Hybrid Vascular Graft. Three month follow-up data for newly created access implants demonstrates a trend toward a reduction in revision procedures, thrombosis events and seroma, as compared to historical graft data. In the United States, more than 300,000 people suffer from ESRD and are in need of dialysis.

The GORE Hybrid Vascular Graft is indicated for use as a vascular prosthesis for dialysis access or bypass for other peripheral vascular diseases. The device is designed to address the most common causes of graft failure; intimal hyperplasia, thrombosis, and seroma. The device simplifies access to vessels with a new over the wire deployment method through a smaller than usual incision in the skin that reduces vessel injury and dissection. The GORE Hybrid Vascular Graft has been used to create new access sites in anatomical locations that would have been abandoned otherwise, preserving the amount of access sites available throughout the patient’s long-term therapy.

Since receiving FDA clearance in 2010, more than 130 patients were treated with the GORE Hybrid Device at multiple centers across the US. John R. Ross, MD , General Surgeon at the Bamberg County Hospital, Bamberg, South Carolina performed the first clinical implants.

“Outflow stenosis has been a long-standing challenge for vascular grafts. The GORE Hybrid Vascular Graft is a promising new option because it targets intimal hyperplasia by creating a sutureless anastomosis that can be created percutaneously,” said Dr. Ross. “This new device directs the outflow so it is in-line with the vessel and shields the area most prone to intimal hyperplasia and failure.”

The GORE Hybrid Vascular Graft combines several trusted Gore technologies. The expanded polytetrafluoroethylene (ePTFE) vascular prosthesis has a section reinforced with nitinol. The nitinol reinforced section is partially constrained to allow for easy insertion and deployment into vessels that are difficult to reach or in challenging anatomical locations. It is the only combination graft that incorporates Carmeda® BioActive Surface (CBAS® Surface) end-point immobilization of heparin to the luminal surface, resulting in a proven thromboresistant surface.

For more information, visit www.goremedical.com.

CDC Director Thomas R. Frieden to Speak at Vascular Disease Foundation Annual Meeting

LAKEWOOD , CO —The Vascular Disease Foundation (VD F) is pleased to announce that Thomas R. Frieden, MD , MPH, Director, Centers for Disease Control and Prevention will be the
keynote speaker at its annual meeting, “Current Issues in Vascular Disease” September 14-15 in McLean, VA .

Dr. Frieden will be speaking on smoking cessation and the public health issue of smoking on September 15th. In addition to Dr. Frieden’s presentation, Dr. Jeffrey Wigand will also be presenting on the same topic. Wigand is the tobacco industry whistleblower who helped the U.S. government in its tobacco settlement case. He was featured on a story on “60 Minutes” and as the character depicted by Russell Crowe in the movie “The Insider.”

VDF’s annual meeting features a dynamic agenda, roundtable discussions and workshops along with VD F’s annual awards dinner where the P.A.D. Coalition and Venous Disease Coalition research and community awards will be presented. The Vascular Disease Foundation President’s and Jacobson awards will also be presented. For more information or to register please visit www.vdf.org/professionals/annualmeeting.php.


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