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.”
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. Safe Harbor Statement This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties may include insufficient insurance coverage or the denial of insurance coverage related to legal costs or any settlement or judgment in connection with legal proceedings, including legal proceedings in which the Company may have an indemnification obligation, compliance with healthcare laws and regulations, adverse impact to our business of the recently enacted healthcare reform bill and related legislation, continued or worsening adverse conditions in the general domestic and global economic markets and continued volatility and disruption of the credit markets, which, among other things, affects the ability of hospitals and other health care systems to obtain credit and may impede our access to capital, market acceptance of excimer laser atherectomy technology, increasing price and product competition, increased pressure on expense levels resulting from expanded sales, marketing, product development and clinical activities, uncertain success of the Company's strategic direction, dependence on new product development, intellectual property claims of third parties, availability of inventory from suppliers, adverse outcome of FDA inspections, the receipt of FDA approval to market new products or applications and the timeliness of any approvals, market acceptance of new products or applications, product defects, ability to manufacture sufficient volumes to fulfill customer demand, availability of vendor-sourced components at reasonable prices, unexpected delays or costs associated with the Company's relocation and consolidation of its manufacturing operations, and price volatility due to the initiation or cessation of coverage, or changes in ratings, by securities analysts. For a further list and description of such risks and uncertainties that could cause the actual results, performance or achievements of the Company to be materially different from any anticipated results, performance or achievements, please see the Company's previously filed SEC reports. Spectranetics disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether as a result of new information, future events or otherwise.
TAPAS is a trademark of ThermopeutiX, Inc.