CardioMend

Apr. 11, 2003 –

SANTA BARBARA, Calif. -- CardioMend LLC, a Santa Barbara based medical device start-up company with offices in St. Louis, Missouri, and Glasgow, Scotland, announced today the first clinical use of its product, AccuMend SL, a set of disposable instruments designed to facilitate stentless aortic valve reconstruction using autologous pericardium. Prof. Gilles Dreyfus, Cardiac Surgeon at the Royal Brompton and Harefield Hospitals in London, performed the operation at Harefield on 14 February 2003. The patient, now at home, is a 42 year-old man who had a calcified bicuspid aortic valve with severe aortic stenosis and an ascending aortic aneurysm. He had been considered a candidate for the Ross Procedure before making the decision to be the first patient to undergo an aortic valve reconstruction with AccuMend SL.

Using the sizing, cutting and holding instruments designed and manufactured by CardioMend, Prof. Dreyfus excised the diseased valve and reconstructed a normal trileaflet valve with the patient’s own pericardium. Prof. Dreyfus commented that, “This represents the most physiological valve substitute currently available. Most of the valves that are called stentless suggests that they have no stent to support the leaflet; that is not completely true, except for this autologous pericardial valve. The pericardium is present in every patient and being the own patient’s tissue, it cannot be subjected to rejection. There is very limited impact of chemical preservation, which can also alter the tissue and finally there are no stents, which are well known to increase sheer stress and subsequently create mechanical dysfunction. This first operation went extremely well and the appearance on transoesophageal echo of the valve was like a native valve. This new valvular substitute may well be the ideal valve if it is proven to last long enough, which of course still remains to be demonstrated.”

Cardiac surgeon and inventor Jack Love, president of CardioMend LLC, said, “Using the patient's own tissue for reconstruction has several advantages which include avoidance of procurement and processing costs of animal or cadaver tissue valves, elimination of an immune response to foreign tissue, a factor that has been implicated in the limited durability of animal and cadaver tissue valves, and avoidance of risk of disease transmission from foreign tissue.”

CardioMend has recently entered into a distribution agreement with Cardio Life Research, s.a., Brussels, which is responsible for the clinical introduction and marketing of AccuMend SL in Europe. CardioMend has obtained the CE Mark for its products and also has FDA approval in the U.S.

If you would like more information about CardioMend please contact us by email at info@cardiomend.com.