Leverkusen/Munich, September 12, 2011 – Medrad, Inc., a business of Bayer HealthCare, today announced it has received CE Mark for its next generation Cotavance® Paclitaxel Coated Balloon Angioplasty Catheter with Paccocath® technology.
Currently available and marketed through the Medrad Interventional business unit, the next generation Cotavance balloon catheter is designed to incorporate innovations that include an improved paclitaxel coating process for controlled drug dosing and a new catheter platform with a full range of catheter sizes. The announcement was made in conjunction with the annual congress of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) in Munich, 10-14 September 2011.
The Cotavance balloon catheter is used in percutaneous interventions for the treatment of peripheral arterial disease (PAD) and is approved for balloon dilation of stenotic lesions in the iliac and infrainguinal arteries while applying paclitaxel to the vessel wall to inhibit restenosis.
Medrad Interventional is also moving forward with the Investigational Device Exemption (IDE) process as one of the steps in gaining FDA approval for Cotavance product in the United States.
Paccocath technology is a proprietary drug matrix applied to the balloon of an angioplasty catheter. The matrix consists of paclitaxel, long used in drug-eluting stents to treat cardiovascular disease, and Ultravist® 370, a radiologic contrast agent. When the balloon is inflated to dilate the narrowed vessel, paclitaxel is delivered directly to the diseased area. Bayer Pharma AG is the owner of the Paccocath technology.
“Our goal is to continue to provide compelling peripheral arterial intervention technology that enables physicians to advance the treatment of PAD and improve patient outcomes,” said Jack Darby, Senior Vice President of Medrad Interventional. “We believe this new Cotavance platform represents a state-of-the-art option for treating PAD patients, from routine to difficult cases.”
In addition to the advances in the Cotavance catheter technology, Medrad Interventional continues to invest in rigorous, randomized studies to better understand treatment options and indications. These studies include the recently announced first-patient enrolled in the ev3 DEFINITIVE AR study using Cotavance balloon catheters (representing the first research application of the next generation Cotavance catheter) sponsored by Covidien, as well as three additional randomized clinical studies including EURO CANAL, COPA CABANA (physician‐sponsored study using Cotavance) and RIVER. Together these studies will involve approximately 90 centers worldwide and include more than 700 patients with the goal of expanding scientific evidence of the Cotavance balloon catheter with Paccocath technology and providing valuable data for the clinical community toward optimized care for patients suffering from PAD.
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