Cardiovascular Systems, Inc. Expands Product Portfolio by Signing Agreement with Invatec
CSI’s flagship product is the Diamondback 360o™ Orbital Atherectomy System, a minimally invasive catheter system for treating peripheral arterial disease (PAD). Between 8 and 12 million Americans suffer from PAD, which is caused by the accumulation of plaque in leg or foot arteries, reducing blood flow. Symptoms include leg pain when walking or at rest, and PAD can lead to tissue loss and eventually limb amputation. The Diamondback 360o is highly effective in removing plaque and restoring blood flow in vessels both below and above the knee. In some cases, balloon angioplasty may also be used to achieve the desired vessel diameter after removing plaque with the Diamondback 360o.
“CSI is committed to developing and offering products specifically designed to treat PAD and to prevent the trauma and costs associated with limb amputation,” said David L. Martin, CSI president and chief executive officer. “The innovative Invatec products and Viper line of supplemental products, including the new ViperSheath, complement and expand our product portfolio, as well as enhance the productivity of our national sales team. These product additions are in line with our mission to provide physicians with the tools they need to treat PAD.”
CSI will offer the Invatec balloon catheter line, including the SubMarine Plus™ PTA Balloon Catheter, the Admiral Xtreme™ PTA Balloon Catheter and the Amphirion Deep™ PTA Balloon Catheter.
Dr. Ray Dattilo, director of peripheral interventions at St. Francis Hospital, Topeka, Kansas, said, “The large diseased vessels above the knee will often become damaged when ballooned, if they are not first made more compliant with Diamondback 360o treatment. We find the Invatec balloons expand with far less pressure after the vessel is treated with the Diamondback 360o, avoiding both dissection and the need to stent.”
“The extensive reach of CSI's sales and marketing team will enable us to fully capitalize on the significant market interest in Invatec's balloon catheter line,” said Jack Springer, president of Invatec USA. “CSI is the ideal partner for us, as it shares our belief in working closely with our physician community to develop endovascular tools that help improve the outcomes of their patients and enhance the quality of their lives.”
CSI Expands Product Portfolio with ViperSheath™ Launch
Additionally, CSI is launching ViperSheath, an introducer sheath providing a smooth, pliable solution for vessel access. A tapered soft tip means low insertion force and minimal trauma on vessel walls during insertion. A kink- and crush-resistant catheter allows for optimal crossability and easy navigation of tortuous vessels. ViperSheath joins a portfolio of existing CSI supplemental products including: ViperSlide™ – an exclusive lubrication designed to optimize the smooth operation of the Diamondback 360º; ViperTrack™ – a radiopaque tape designed to assist in identifying lesion lengths and the best treatment strategy for procedures using fluoroscopic or radiographic imaging, and ViperWire™ a spring tip guidewire with flexible or firm stiffness profiles, specifically designed for the Diamondback 360º™ to achieve maximum performance. All products are available through the CSI national sales organization.
About Cardiovascular Systems Inc.
Cardiovascular Systems Inc. is a medical device company focused on developing and commercializing interventional treatment systems for vascular disease. The company’s Diamondback 360° Orbital Atherectomy System is capable of treating a broad range of plaque types both above and below the knee, including calcified vessel lesions, and addresses many of the limitations associated with existing treatment alternatives. In August 2007, the U.S. FDA granted 510(k) clearance for the use of the Diamondback 360° as a therapy for PAD (peripheral arterial disease), and CSI commenced a U.S. product launch in September 2007. The Diamondback 360° system has been adopted by more than 400 hospitals across the United States. For more information visit the company’s Web site at www.csi360.com.
Contact:
For Cardiovascular Systems, Inc. Investor Relations, 651-259-2800 investorrelations@csi360.com or For Invatec: Jasmine Fielding, 781-684-0770 invatec@schwartz-pr.com or Padilla Speer Beardsley: Marian Briggs, 612-455-1742 mbriggs@psbpr.com Nancy A. Johnson, 612-455-1745 njohnson@psbpr.com