COLORADO SPRINGS,
Colo.–(BUSINESS WIRE)–Spectranetics
Corporation 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. Elizabeths 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.”
Scott Drake, President and Chief Executive Officer of
Spectranetics, stated, “The TAPAS catheter is a novel approach to delivering
therapeutic agents to the peripheral vasculature and fits nicely with our
portfolio of devices that allow physicians to cross, prepare, and remove
stenoses while preserving native vessels. This partnership is an important next
step in our continued drive to provide physicians new and innovative solutions
that address the challenges of peripheral vascular disease.”
“We are happy to be partnering with Spectranetics on this
product,” said Ron Solar, CEO of ThermopeutiX. “With our innovation and
manufacturing combined with their high quality sales and marketing teams, we
are enthusiastic about the success of the TAPAS catheter.”
About Spectranetics
Spectranetics develops, manufactures, markets and distributes 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 the heart and legs as well as the
removal of pacemaker and defibrillator leads.
The Company’s Vascular Intervention (VI) products include a
range of peripheral and cardiac laser catheters for ablation of occluded
arteries above and below the knee and within coronary arteries. The Company
also markets aspiration and thrombectomy catheters for the removal of thrombus
and support catheters to facilitate crossing of coronary and peripheral
arterial blockages.
The Lead Management (LM) product line includes excimer laser
sheaths and cardiac lead management accessories for the removal of pacemaker
and defibrillator cardiac leads.
For more information, visit www.spectranetics.com.
Posted by Sean Fenske, Editor-in-Chief, MDT
