Healthcare Industry News: thrombosis
News Release - October 8, 2012
Spectranetics Announces U.S. Launch of the TAPAS(TM) Catheter and Preclinical Animal Data on Drug Uptake in Peripheral VesselsCOLORADO SPRINGS, Colo., Oct. 8, 2012 -- (Healthcare Sales & Marketing Network) -- Consistent with its commitment to eradicating restenosis and amputations, Spectranetics Corporation (SPNC) today announced the U.S. market launch of the TAPAS catheter at the 2012 Vascular Interventional Advances (VIVA) conference in Las Vegas. TAPAS is manufactured by ThermopeutiX, Inc. and distributed by Spectranetics. In conjunction with the launch at VIVA, Dr. Mehdi Shishehbor, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH will present his study results on preclinical animal data at VIVA Continuing Medical Education event titled "Contemporary Options for Complex Lower Extremity Disease." This CME event is supported by an unrestricted educational grant from Spectranetics. The purpose of the study was to evaluate the uptake of a drug delivered intra-arterially via the TAPAS(TM) Catheter in a swine model.
The TAPAS catheter is the first drug infusion system to provide a versatile solution using a single adjustable and repositionable catheter to deliver any physician-specified drug or diagnostic agent. Its dual occlusion balloon design allows for precise targeting of the treatment area, delivery and dwell time of the drug, and aspiration to minimize systemic effects.
"The addition of TAPAS to our portfolio reflects our recognition of the clinical need for localized drug therapy within peripheral arteries," said Jason Hein, Senior Vice President and General Manager of Vascular Intervention at Spectranetics. "This is an exciting opportunity for physicians to provide an adjunctive therapy to their patients whose recurrent disease has not been successfully managed with existing treatment options."
Dr. Rich Kovach, Chief of Interventional Cardiology, Deborah Heart and Lung Center, stated, "I have found the TAPAS catheter to be very easy to use and the versatility is quite appealing. The adjustability of the device allows lesions from 15mm to 300mm to be treated with one device, and it can be used to treat multiple lesions within a single vessel. The device also allows the physician to choose the agent that would best serve the patient's clinical presentation. Using a device with such versatility also provides potential for significant economic benefit over other technologies, which can only be used once in the same patient, and need to be stocked in multiple sizes."
The TAPAS catheter provides physicians a unique option for localized drug delivery to help address the growing clinical need for new treatments for peripheral arteries. According to The Sage Group, PAD of the lower extremities affects approximately 17 million people in the United States1, although many patients are unaware of their condition or the seriousness of it. PAD patients have a 2 to 3 X increased risk for cardiovascular disease and a significantly increased risk of amputation, disability and diminished quality of life.2
About the TAPAS(TM) Catheter
The TAPAS catheter is an innovative system featuring two compliant occlusion balloons enabling targeted local infusion 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.
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 more than 40 countries 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.
VIVA Physicians is a not-for-profit physician organization dedicated to advancing the field of vascular medicine and intervention through education and research. Since 2003, VIVA Physicians has held an annual multidisciplinary vascular education conference in Las Vegas, Nevada where recognized experts and attendees from all around the world come to explore innovative technologies and therapies for vascular disease to improve vascular patient care.
For more information, please visit www.VIVAPVD.com. Follow us on Twitter: www.twitter.com/VIVAPVD.
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.
For more information, visit http://www.spectranetics.com.
1. Yost, M.L., (2011). The real cost of peripheral artery disease. The Sage Group, LLC.
2. Fowkes, F.G.R., Low, L., Tuta, S., and Joseph Kozak, J. on behalf of the AGATHA Investigators. 2006 Ankle-brachial index and extent of atherothrombosis in 8891 patients with or at risk of vascular disease: results of the international AGATHA study. European Heart Journal, 27, 1861-1867
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