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Spectranetics strengthens peripheral vascular portfolio with distribution partnership.

Spectranetics Corporation has formed a partnership agreement to commercialize its TAPAS catheter, a therapeutic infusion system that recently received U.S. Food and Drug Administration (FDA) 510(k) clearance. The product, intended for targeted infusion of therapeutic and diagnostic agents in the peripheral vasculature, is being launched through an agreement with ThermopeutiX Inc., in a limited number of U.S.-based and European hospitals.

The TAPAS catheter features two compliant occlusion balloons that enable targeted local delivery of any physician-specified agent. One of the device's unique features is the ability to adjust the treatment zone up to 300 millimeters, allowing for the treatment of long vessels with only one device and, in certain cases, multiple lesions with one device. The medication can be removed from the catheter after treatment, providing localized intravascular treatment without systemic runoff. The TAPAS catheter can be used in conjunction with Spectranetics' laser atherectomy or other interventional devices, according to the company. Clinical studies are currently underway to investigate whether debulking with laser or other atherectomy devices prior to drug delivery improves patient outcomes.

"I am very excited to begin working with the new TAPAS catheter," said Lawrence Garcia, an M.D. at St. Elizabeth's Medical Center in Boston, Mass. "Endovascular treatment is becoming an increasingly targeted therapy approach for our patients. We currently do not have a device that can provide local drug delivery while minimizing systemic effects and be adaptable to a wide variety of patients and anatomies. Although we are years away from the availability of other targeted therapeutic and diagnostic delivery systems in the United States, the TAPAS catheter provides an opportunity for local drug delivery for our patient needs now."

The first procedures were performed by Eric Dippel, M.D., at Trinity Medical Center in Bettendorf, Iowa. "The TAPAS catheter provides a flexible platform for a variety of applications," Dippel noted. "I was able to use the product to deliver different drugs tailored to the patients' clinical situations."

Spectranetics President and CEO Scott Drake said the partnership with ThermopeutiX will enable doctors to address a greater number of patients with peripheral vascular disease. He called the TAPAS catheter a "novel approach to delivering therapeutic agents" to the peripheral vasculature and said the company's agreement is an "important next step" in helping clinicians address the challenges of peripheral vascular disease. "The TAPAS catheter ... fits nicely with our portfolio of devices that allow physicians to cross, prepare and remove stenoses while preserving native vessels," he said.

Based in Colorado Springs, Colo., Spectranetics develops single-use medical devices used in minimally invasive procedures within the cardiovascular system. The company's products are sold in 40 countries throughout the world and are used to treat arterial blockages in both the heart and legs. Spectranetics devices also are used to help remove pacemaker and defibrillator leads.

The company's vascular intervention products include a range of peripheral and cardiac laser catheters for ablation of occluded arteries above and below the knee and with coronary arteries. Spectranetics also markets aspiration and thrombectomy catheters for the removal of thrombus and support catheters to facilitate the crossing of coronary and peripheral arterial blockages.

ThermopeutiX is a private company based in San Diego, Calif., that has developed a dual-lumen catheter system that removes warm blood from the body through one lumen and delivers cold blood to the brain through a second lumen, according to a brief summary in Elsevier Business Intelligence. The technology is designed to be used primarily by interventional cardiologists and interventional radiologists to treat stroke, cardiac arrest and trauma.
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Title Annotation:Industry News
Publication:Medical Product Outsourcing
Date:Mar 1, 2012
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