St. Jude Medical Company, a manufacturer of medical devices for the global cardiovascular market, has received the "Conformité Européenne" (CE) Mark approval for the design of the new SJM Regent mechanical heart valve. For the first time, advanced supercomputer modelling tools have been applied in the development process to enhance the quality of the mechanical valve product line. The CE Mark approval offers the best imaginable promotion to allow the sales of this latest edition within St. Jude Medical's family of "gold standard" mechanical heart valves across the European Union.
St. Jude Medical Company has a long standing experience in the design, production and testing of pyrolytic carbon heart valves. The new SJM Regent valve is wearing a supra-annular cuff while the outside profile of the carbon has been submitted to small design modifications. As a result, the hemodynamic performance has been substantially improved in order to offer the mechanical valve patient a whole series of unprecedented hemodynamic advantages. For the rest, the SJM Regent aortic valve maintains the same basic design of all the blood contacting surfaces, found in previous editions of St. Jude Medical mechanical valves.
The earlier mechanical valve versions already have proven to show the lowest complication rates in the entire industry and equally display an exceptional structural integrity. In turn, the SJM Regent holds the essential features to continue the tradition of favourable clinical performance and durability. Up till now, St. Jude Medical Company can be proud of an impressive list of no less than 900.000 successful implants. With the recent availability of tools for supercomputer modelling, the use of innovative design enhancement has been introduced to the development and manufacturing of the SJM Regent.
The new valve has been submitted to severe and extensive in-vitro testing as well as to clinical implants at selected cardiology centres around the world. Clinicians expressed sheer delight and enthusiasm in their first reactions, so the company's Heart Valve Division has decided to immediately launch the SJM Regent valve in Europe and Canada whereas the United States clinical trials will start in the second quarter of 1999. In addition, St. Jude Medical also provides cardiac rhythm management systems, speciality catheters, and a wide range of other cardiovascular devices.