Irvine, Calif., June 12, 2000 – Edwards Lifesciences Corporation (NYSE: EW) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to begin commercial sales of its Thrombex PMT (Percutaneous Mechanical Thrombectomy) System, a device for removing blood clots from the access grafts of hemodialysis patients.
The Thrombex PMT System is a self-contained, disposable clot-removal device that uses a motor-driven catheter and vacuum source to break up and remove thrombi (blood clots) from the patient’s hemodialysis graft. A rotating helical screw at the end of the catheter reduces thrombi into tiny fragments, which are evacuated through the catheter into an attached collection container. The system can be set up in minutes by a single clinician and requires no capital equipment or additional personnel.
"The Thrombex PMT System represents the latest innovation in our broad range of vascular products that includes the Fogarty line of catheters and Lifespan ePTFE Grafts,” said Michael A. Mussallem, chairman and CEO of Edwards Lifesciences. “The system is safe and effective at removing blood clots and is designed to be minimally invasive, making the procedure more comfortable for the patient. It’s also easy for the clinician to use.”
The Thrombex PMT System features a 6 French catheter with a braided-shaft design and is compatible with a 0.018-inch guidewire for easy insertion. The catheter attaches to an easy-to-grip handle to aid the clinician’s movements during insertion and operation.
About Hemodialysis and End-Stage Renal Disease
According to the latest government figures, more than 200,000 Americans undergo hemodialysis for the treatment of end-stage renal disease (ESRD), at an estimated annual cost of more than $10 billion. The leading causes of ESRD are diabetes, high blood pressure and glomerulonephritis. The National Kidney Foundation estimates that more than 35,000 patients in the United States are awaiting kidney transplants, but that only about 11,000 will receive them due to a shortage of suitable organ donors.
While awaiting transplantation, many ESRD patients undergo hemodialysis treatments, often lasting many hours, several times a week, in order to filter out blood contaminants that have built up due to impaired kidney function. An external blood-filtering device, called a dialyzer, is used to clean the blood of excess wastes.Since many people are not suited for an arteriovenous fistula (the joining of an artery and vein under the skin), they require implantation of a synthetic graft, typically made of a material known as expanded polytetrafluoroethylene or ePTFE. While these grafts provide the necessary access to the patient’s vascular system, blood clots can frequently form in them, restricting blood flow and inhibiting the hemodialysis treatment. Such clotting is a contributing factor in many hospitalizations and complications among dialysis patients.
Edwards Lifesciences is debuting the Thrombex PMT System at the 54 th annual meeting of the Society for Vascular Surgery, which continues through June 14 at the Metro Toronto Convention Center in Toronto (booth No. 825).
The Thrombex PMT System is part of Edwards Lifesciences’ family of vascular products that includes the Fogarty line of Arterial Embolectomy, guidewire-compatible Thru-Lumen Embolectomy, Adherent Clot and Graft Thrombectomy catheters.Additionally, Edwards’ Lifespan ePTFE Grafts, Fogarty Surgical Spring Clips and Inserts for atraumatic occlusion, and its line of visualization products, provide clinicians with a complete vascular management system.
Edwards Lifesciences designs, develops and markets a comprehensive line of products and services to treat late-stage cardiovascular disease. Headquartered in Irvine, California, Edwards focuses on cardiac surgery, critical care, vascular systems and perfusion products and services, and is a worldwide leader in tissue replacement heart valves and heart valve repair products. With pro forma sales of more than $800 million in 1999, the company has a strong international presence in over 80 countries and generates more than 35 percent of its sales outside of the United States. Edwards’ extensive manufacturing operations are located in North America, Europe, Japan (through a contractual joint venture with Baxter International) and Latin America. Additional information about Edwards Lifesciences can be found at
www.edwards.com.
This news release includes forward-looking statements that involve risks and uncertainties, including those related to timing or results of pending or future clinical trials, actions by the U.S. Food and Drug Administration and European Union, technological advances in the medical field, product demand and market acceptance, the effect of economic conditions and other risks detailed in the company's filings with the Securities and Exchange Commission. These forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though are inherently uncertain and difficult to predict. Actual results or experience could differ materially from the forward-looking statements.Thrombex PMT, Fogarty and Lifespan are trademarks of Edwards Lifesciences Corporation. Fogarty is registered in the U.S. Patent and Trademark Office.