Healthcare Industry News: hemodialysis
News Release - June 18, 2007
Kensey Nash Announces Results of EU Coronary Study Using the Thromcat(TM) Thrombectomy Catheter SystemEXTON, Pa., June 18 (HSMN NewsFeed) -- Kensey Nash Corporation (Nasdaq: KNSY ) today announced that it has completed a European Union (EU) study to assess the device success, safety and performance of the ThromCat(TM) Thrombectomy Catheter System during percutaneous coronary intervention (PCI). The trial enrolled over 60 patients at seven sites, and was designed to study outcomes of patients in both acute and elective PCI settings, who had thrombus present in their native coronary arteries. The ThromCat(TM) System is a mechanical thrombectomy catheter designed to remove thrombus (blood clots) in patients, and is indicated in Europe for use in both coronary and certain peripheral arteries.
Hospital discharge results, presented by the Company at the EuroPCR meeting in Barcelona last month, demonstrated over 90% device success, patient safety and desired device performance with 70% thrombus removal by volume. The results of the study also showed strong improvements to TIMI flow measurements, and myocardial blush scores, based on the use of the ThromCat(TM) System, with only 1.6% of the patients needing temporary pacing. Over half of the patients enrolled had presented with an acute myocardial infarction (MI). Professor Michael Haude, M.D., Director of Medizinische Klinik I, Lukaskrankenhaus, Neuss, Germany, served as the principal investigator for the study, which took place in Germany.
"We were very pleased with the ThromCat(TM) System performance during the study. Not only did the system show itself to be safe and effective in removing thrombus in the coronary setting, it was also very easy to use. I am very appreciative of the power of this device particularly in the large coronary arteries. The device also appears to lessen the need for temporary pacing during these challenging procedures," commented Professor Haude.
The ThromCat(TM) mechanical thrombectomy system is a fully disposable catheter system that incorporates HeliFlex(TM) technology to flush, macerate, and extract thrombus. An internal rotating helix creates a powerful vacuum to draw thrombus into the catheter and then macerate it, while simultaneously flushing the vessel to aid in the thrombus removal. The Company believes that the worldwide market for thrombus removal could expand with this offering of a more simple and effective device.
The ThromCat(TM) System is sold internationally through a direct sales force in Germany and through a distribution network covering the European Union and certain other parts of the world. In the U.S., the device is indicated for mechanical removal of thrombus from synthetic hemodialysis access grafts and native vessel dialysis fistula, and is sold through Kensey Nash's direct sales force.
The ThromCat(TM) Thrombectomy Catheter System is part of Kensey Nash's thrombus management product platform, which includes the QuickCat(TM) Extraction Catheter, cleared in the U.S. and Europe for the removal of thrombus from vessels in the arterial system. The QuickCat(TM) Extraction Catheter is an easy to use, disposable device designed for soft thrombus burdens. Kensey Nash also offers the TriActiv® embolic protection platform and the Safe-Cross® Chronic Total Occlusion (CTO) System, which is indicated in the U.S. for use in facilitating the placement of devices used in interventions of total occlusions in both coronary and peripheral arteries. The Safe-Cross® System utilizes radio frequency (RF) energy for powering through CTOs and Optical Coherence Reflectometry (OCR) for guidance in a wire based platform.
About Coronary and Peripheral Vascular Disease: Coronary and Peripheral Vascular Disease (PVD) are forms of Cardiovascular Disease. According to the latest statistics from The World Health Organization, Cardiovascular Disease is the leading cause of death globally. 17.5 million people died from Cardiovascular Disease in 2005, representing 30 percent of all global deaths. 7.6 million of those were due to Coronary Heart Disease (CHD). CHD is a disease of the blood vessels supplying the heart muscle and major risk factors include high blood pressure, high cholesterol, tobacco use, unhealthy diet, physical inactivity, diabetes, advancing age and inherent disposition. PVD, a disease of the arteries supplying the arms and legs, is a precursor to coronary heart disease and diabetes. Coronary and Peripheral Vascular Disease are treated by Interventional Cardiologists, Vascular Surgeons or Interventional Radiologists.
About Kensey Nash Corporation: Kensey Nash Corporation is a leading medical technology company providing innovative solutions and technologies for a wide range of medical procedures. The Company provides an extensive range of products into multiple medical markets, primarily in the endovascular, sports medicine and spine markets. Many of the products are based on the Company's significant expertise in the design, development, manufacturing and processing of absorbable biomaterials, which has led to partnerships in commercializing leading technologies. Kensey Nash has also commercialized a series of innovative embolic protection and thrombectomy products through its own direct endovascular sales force. The Company is known as a pioneer in the field of arterial puncture closure, as the inventor and developer of the Angio-Seal(TM) Vascular Closure Device, which is licensed to St. Jude Medical, Inc.
Cautionary Note Regarding Forward-Looking Statements. This press release contains forward-looking statements that reflect Kensey Nash's current expectations about its prospects and opportunities, including, without limitation, expectations regarding Kensey Nash's ThromCat(TM) System and its other endovascular products. Kensey Nash has tried to identify these forward- looking statements by using words such as "plans," "believes," "expects," "anticipates," "will," "should" or similar expressions, but these words are not the exclusive means for identifying such statements. Kensey Nash cautions that a number of risks, uncertainties, and other important factors could cause Kensey Nash's actual results, performance or achievements to differ materially from those expressed in, or implied by, these forward-looking statements, including, without limitation, the ability of Kensey Nash to successfully market its endovascular products, and competition from other technologies in the embolic protection and thrombectomy markets. For a more detailed discussion of these and other factors, please see Kensey Nash's filings with the Securities and Exchange Commission. Except as expressly required by the federal securities laws, Kensey Nash undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.
Source: Kensey Nash
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