News + New Products

LeMaitre Vascular Acquires InaVein

LeMaitre Vascular, Inc., a provider of peripheral vascular devices and implants, acquired the assets of InaVein, LLC for $2.5mm, or 1.1X InaVein’s 2012 sales, and potential earn-out payments in 2014 and 2015 based on the performance of the acquired business and regulatory approval in China.

InaVein owned and marketed the TRIVEX® System, a business that carried a 60-70% gross margin.

TRIVEX is a system comprised of capital equipment and disposables that enables less invasive removal of varicose veins. In this procedure, an illuminator instrument is inserted through a small incision into the leg, enabling visualization of varicose veins. A second instrument removes the veins. Compared to conventional hook phlebectomy, this surgical procedure is faster and results in more complete vein removal through fewer incisions.

This acquisition introduces a new product line to the LeMaitre Vascular sales bag and builds LeMaitre Vascular’s presence in the varicose vein market. Because InaVein is a 4 employee company based in Lexington, MA—less than 5 miles from LeMaitre Vascular’s headquarters—LeMaitre Vascular anticipates a smooth integration process.

“TRIVEX is a unique solution for the removal of varicose vein branches, a niche not effectively addressed through devices that focus on the greater saphenous vein. This transaction fits nicely into LeMaitre’s playbook of acquiring under-marketed devices at an attractive price, and bringing them to more potential vascular surgeon customers through the expansive reach of our direct sales force,” said David Roberts, President of LeMaitre Vascular.

About LeMaitre Vascular

LeMaitre Vascular is a provider of devices and implants for the treatment of peripheral vascular disease, a condition that affects more than 20 million people worldwide. The Company develops, manufactures and markets disposable and implantable vascular devices to address the needs of its core customer, the vascular surgeon. The Company’s diversified product portfolio consists of brand name devices used in arteries and veins outside of the heart. Additional information can be found at http://www.lemaitre.com.

LeMaitre, the LeMaitre Vascular logo and TRIVEX are registered trademarks of LeMaitre Vascular, Inc.

Covidien Releases Clinical Data Supporting Treatment and New Approach to Peripheral Arterial Disease

Covidien, a leading global provider of healthcare products, has released positive final results from its DURABILITY II study and promising preliminary data from its DEFINITIVE AR trial at the Vascular Interventional Advances (VIVA) 2013 conference in Las Vegas, NV. These studies demonstrate the safety and effectiveness of technologies used in the treatment of peripheral arterial disease (PAD). The DURABILITY II three-year results support the use of a single long EverFlexTM self-expanding stent. DEFINITIVE AR acute 30-day data shows early success with the combined use of directional atherectomy and a drug-coated balloon (DAART) in treating lower limb blockages in PAD patients.

The DEFINITIVE AR study evaluated the use of directional atherectomy with Covidien’s TurboHawkTM plaque excision system.

“Covidien’s extensive clinical research program in vascular therapies aims to provide rigorous evidence that physicians can use to make treatment decisions for conditions, such as peripheral arterial disease -- a common vascular disease affecting over 200 million people worldwide, “ said Mark Turco, M.D., Chief Medical Officer, Covidien Vascular Therapies. “Providing clinically relevant data -- like the DURABILITY II and DEFINITIVE AR trials - to physicians is a must, and I’m proud of Covidien’s work to drive this evidence.”

In DURABILITY II, the use of the EverFlexTM stent demonstrated a low need for repeat procedures (revascularization of treated lesions) as well as a low rate of stent breakage (fracture rate). Stent fracture is a known cause of artery reblockage leading to repeat procedures. Final results support the long-term safety and effectiveness of the EverFlex stent in a challenging PAD patient population.

In the DEFINITIVE AR randomized study, early results show that physicians are achieving better acute procedural success when treating patients with directional atherectomy plus anti-restenotic therapy (DAART) versus using a drug-coated balloon alone. The results also showed superior lumen gain with DAART treatment with fewer vessel tears (dissections) and no “bailout” stents required.

For a summary of research findings, please visit Covidien DURABILITY II and Covidien DEFINITIVE AR.

About Covidien

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading products in medical devices and supplies. With 2012 revenue of $9.9 billion, Covidien has 38,000 employees worldwide in 70 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

Boston Scientific Begins Clinical Trial Of Innova Peripheral Vascular Drug-Eluting Stent System

Launching a key clinical trial expected to serve as the foundation for global regulatory approvals, a physician in Auckland, New Zealand has performed the first patient implant of the Boston Scientific Corporation Innova™ Drug-Eluting Stent (DES) System. The MAJESTIC trial -- designed to evaluate the safety and performance of the first Boston Scientific peripheral drug-eluting stent system -- is projected to enroll 55 patients across 15 centers in Europe, Australia and New Zealand. The Innova DES System reflects more than a decade of Boston Scientific experience in drug-eluting technologies.

The Innova DES System is designed to restore blood flow in arteries above the knee, specifically the SFA and proximal popliteal artery (PPA). The stent features a unique drug-polymer combination, intended to facilitate optimal release of the drug and prevent restenosis (narrowing) of the vessel. The first implant was performed by Andrew Holden, M.D., director of Interventional Radiology at Auckland City Hospital, Auckland, New Zealand.

“The complex anatomy of the superficial femoral artery above the knee and the dynamic forces created by flexion of the knee create a challenging environment for implants like stents, leading to the potential risk of stent fracture and higher rates of restenosis,” said Professor Stefan Muller-Hulsbeck, M.D., PhD, deputy chairman Vascular Center Diako Flensburg and Head of the Dept. of Diagnostic and Interventional Radiology-Neuroradiology, Academic Hospitals Flensburg, Germany. “The Innova DES System combines the benefits of the clinically-proven drug Paclitaxel with architecture and stent design purpose-built for use in the SFA and PPA. The deliverability, flexibility and durability in combination with the anti-restenotic characteristics of the Innova DES System make it ideal for use treating lesions in these critical arteries.”

Professor Muller-Hulsbeck serves as principal investigator of the MAJESTIC trial.

The Innova DES System consists of a Paclitaxel- coated, Nitinol, self-expanding stent loaded on an advanced, low-profile delivery system. The innovative stent architecture features a closed-cell design at each end of the stent for more consistent deployment, and an open-cell design along the stent body for improved flexibility and fracture resistance. Deployment accuracy is facilitated by a tri-axial catheter shaft designed to provide added support and placement accuracy.

“Millions of patients around the world suffer the debilitating effects of peripheral artery disease (PAD), including amputation and an elevated risk for major cardiovascular events,” said Jeff Mirviss, president, Peripheral Interventions, Boston Scientific. “The Innova DES System builds upon the Boston Scientific leadership in both peripheral vascular devices and drug-eluting technologies, and we look forward to bringing this meaningful innovation forward to improve outcomes for patients with PAD.”