Spectranetics to Market Thermopeutix's Tapas Peripheral Infusion Catheter

January 24, 2012—Spectranetics Corporation (Colorado Springs, CO) announced an agreement with Thermopeutix, Inc. (San Diego, CA) to commercialize the Thermopeutix Tapas catheter. The Tapas system is intended for targeted infusion of therapeutic and diagnostic agents in the peripheral vasculature.

According to Spectranetics, the Tapas catheter recently received 510(k) clearance from the US Food and Drug Administration. The device had been submitted for CE Mark approval for marketing in Europe. It will be launched in a limited number of hospitals in the United States and Europe during the first quarter of 2012.

The Tapas catheter features two compliant occlusion balloons that enable targeted local delivery of any physician-specified agent. It has the ability to adjust the treatment zone up to 300 mm, allowing for the treatment of long vessels with only one device and, in certain cases, multiple lesions with one device. The medication can be aspirated out of the catheter after treatment, providing localized intravascular treatment without systemic runoff.

The company noted that the Tapas catheter can be used in conjunction with Spectranetics' laser atherectomy or other interventional devices. Clinical studies are currently underway to investigate whether debulking with laser or other atherectomy devices before drug delivery improves patient outcomes, stated Spectranetics.

“I am very excited to begin working with the new Tapas catheter,” commented Lawrence Garcia, MD. “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.”