Spectranetics Corporation (Nasdaq:SPNC) today announced an agreement with ThermopeutiX, Inc. to commercialize the TAPAS catheter, a therapeutic infusion system. The product has recently received U.S. Food and Drug Administration (FDA) 510(k) clearance and is awaiting the issuance of a CE certificate. It will be launched in a limited number of US and European hospitals in the first quarter of 2012. The TAPAS catheter is intended for targeted infusion of therapeutic and diagnostic agents in the peripheral vasculature.
The TAPAS catheter is an innovative system featuring two compliant occlusion balloons enabling targeted local delivery of any physician-specified agent. A unique feature of the device is the ability to adjust the treatment zone up to 300mm, 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 run-off. 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 prior to drug delivery improves patient outcomes.
“I am very excited to begin working with the new TAPAS catheter,” said Dr. Lawrence Garcia, St. Elizabeth’s Medical Center in Boston. “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 Dr. Eric Dippel at Trinity Medical Center in Bettendorf, Iowa. “The TAPAS catheter provides a flexible platform for a variety of applications,” said Dr. Dippel. “I was able to use the product to deliver different drugs tailored to the patients’ clinical situations.”