Healthcare Industry News: HeartMate II
News Release - August 24, 2006
Thoratec and Levitronix Announce U.S. Co-Distribution Agreement for Levitronix(R) CentriMag(R) SystemTransaction Broadens Thoratec Circulatory Support Portfolio With Addition of Short-Term System
PLEASANTON, Calif., Aug. 24 (HSMN NewsFeed) -- Thoratec Corporation (Nasdaq: THOR ) and Levitronix LLC today announced they have signed a co- distribution agreement under which Thoratec will distribute the Levitronix CentriMag Blood Pumping System in the U.S. The agreement is effective through December 2011.
The Levitronix device currently has FDA 510k approval in the U.S. for use in patients requiring short-term extracorporeal (i.e. -- outside the body) circulatory support during cardiac surgery. It has CE Mark approval and is commercially available throughout Europe to support patients in severe, potentially reversible ventricular failure for up to 14 days.
The device recently completed three successful pilot trials in the U.S. to demonstrate safety in patients suffering from cardiogenic shock, experienced after cardiac surgery or acute myocardial infraction (AMI), and for patients requiring short term right ventricular support. Levitronix is currently in discussion with the FDA regarding an IDE (Investigational Device Exemption) to begin a pivotal trial later this year to demonstrate safety and effectiveness of the CentriMag for any cardiac condition resulting in ventricular failure where there is an opportunity for recovery. These include but are not limited to AMI, post-cardiotomy cardiogenic shock, acute myocarditis, intractable ventricular arrhythmias, failed transplant and postpartum cardiomyopathy. The company estimates the market opportunity for these indications to be $40 - $100 million but does not expect this agreement to represent a meaningful contribution to revenues for the balance of 2006.
"We are delighted to be expanding our relationship with Levitronix, our development partner for the HeartMate® III centrifugal, continuous flow pump," said Gary F. Burbach, president and chief executive officer of Thoratec. In a separate transaction, Thoratec is investing $5 million in Levitronix through a convertible debt instrument that matures in 2013.
"The Levitronix device is exciting, state-of-the art, recovery and bridge to decision technology utilizing the same magnetically levitated, contact-free technology used in our HeartMate III. This agreement complements and broadens our offerings of circulatory support devices and leverages the strong presence of our sales force in the market," he added.
"This partnership is a win-win. We've had great success with over 350 implants worldwide. This relationship allows us to focus on accelerating our U.S. clinical trials and to continue to increase sales throughout the rest of the world while Thoratec's sales force assists us in penetrating the U.S. market," said Dr. Kurt A. Dasse, chief executive officer of Levitronix.
"This agreement represents a strong strategic fit for Thoratec. It allows us to expand more broadly beyond transplant centers and enables us to better address opportunities in short-term patient recovery. The device is easy to implant and is designed to reduce device-related adverse events, such as hemolysis or thrombosis," noted Jeffrey Nelson, president of Thoratec's Cardiovascular Division. "Additionally, we are excited about the preliminary clinical results and the upcoming pivotal trial which we believe will demonstrate the CentriMag's ability to serve as a bridge to decision device in those patients whose hearts are not recoverable and who may require long-term circulatory support options, such as our Thoratec and HeartMate VADs."
According to Andrew Boyle, MD, Assistant Professor of Medicine, Division of Cardiology, University of Minnesota Medical Center, one of the CentriMag pilot clinical trial sites, "Currently, these patients are simply dying without intervention at many institutions, even ones that implant VADs. Therefore, there is a need for a simple and cost-effective way to allow for a bridge to decision on a patient's candidacy for bridge to transplantation. Our data suggests that the use of this device may ultimately increase the pool of patients for bridge to transplantation as these are new patients for devices."
Thoratec Corporation is a world leader in therapies to address advanced stage heart failure. The company's product line includes the Thoratec® VAD (Ventricular Assist Device and HeartMate LVAS (Left Ventricular Assist System) with more than 10,000 devices implanted in patients suffering from heart failure. Additionally, its International Technidyne Corporation (ITC) division supplies blood testing and skin incision products. Thoratec is headquartered in Pleasanton, California. For more information, visit the company's web sites at http://www.thoratec.com or http://www.itcmed.com .
Levitronix LLC is a world leader in designing, developing, manufacturing and selling bearingless motor technology for medical and industrial applications. The company's medical product line includes the CentriMag® Extracorporeal Blood Pumping System to provide mechanical circulatory support for patients undergoing cardiac surgical procedures. Levitronix is currently conducting clinical trials in the U.S. to evaluate the CentriMag VAS for short-term support as a bridge to decision to treat one or both sides of the heart for patients in potentially reversible heart failure when it is uncertain whether the patient will recover, need a long-term VAD or need to undergo transplantation. The CentriMag VAS is CE Marked and commercially available throughout Europe. For more information, visit www.levitronix.com . Levitronix is headquartered in Waltham, Massachusetts, with a wholly-owned subsidiary based in Zurich, Switzerland.
CAUTION -- The CentriMag VAS is an Investigational Device in the U.S. Limited by Federal (USA) law to investigational use.
Many of the preceding paragraphs, particularly but not exclusively those addressing the performance of the Levitronix device and its contributions to Thoratec, contain 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. These statements can be identified by the words, "expects," "projects," "hopes," "believes," "could," "suggests," and other similar words. Actual results, events or performance could differ materially from these forward-looking statements based on a variety of factors, many of which are beyond Thoratec's control. Therefore, readers are cautioned not to put undue reliance on these statements. Investors are cautioned that all such statements involve risks and uncertainties, including risks related to the development of new markets, the growth of existing markets for our products, customer and physician acceptance of Thoratec products, the results of, enrollment in and timing of clinical trials, regulatory approval processes, the effects of healthcare reimbursement and coverage policies, the effects of price competition from any Thoratec competitors and the effects of any merger and acquisition related activities. Forward-looking statements contained in this press release should be considered in light of these factors and those factors discussed from time to time in Thoratec's public reports filed with the Securities and Exchange Commission, such as those discussed under the heading, "Risk Factors," in Thoratec's most recent annual report on form 10-K. These forward-looking statements speak only as of the date hereof. Thoratec undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
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