October 7, 2011 – ValveXchange Inc., has performed successful first-in-man (FIM) surgeries demonstrating the practicality and advantages of its novel Vitality two-part heart valve system. Two renowned United States cardiac surgeons, Lars Svensson, M.D., Ph.D., of The Cleveland Clinic and W. Randolph Chitwood, M.D. of The East Carolina Heart Institute, performed the surgeries; they were working with Adrian Ebner, M.D. at his facilities in Asuncion, Paraguay.
The surgeries took place Sept. 26-27, 2011. Three men aged 49, 62 and 72 received the Vitality heart valves. All have been discharged and are recovering normally.
Currently, tissue valves are recommended only for older patients because the leaflet sets wear out every 10-15 years, requiring repeated open-heart surgeries. Younger patients today receive mechanical heart valves that do not wear out, but require lifelong high doses of anticoagulation drugs forcing a sedentary lifestyle with serious side effects.
The ValveXchange concept is a two-part valve with a permanently implanted base and an easily replaceable leaflet set. The leaflet set is designed to be replaced transapically (through the apex of the heart), accessed by a small incision between the ribs and not requiring any future open-heart surgeries.
The company is currently developing the tool set for the transapical leaflet replacement procedure. Leaflets can also be replaced using standard and minimally invasive surgical techniques that are faster and simpler than traditional valve replacement surgeries.
Of the surgeries Chitwood said, “These cases went extremely well. We think we’ve got an excellent valve concept. You can look below the valve before you put the leaflet set in and see exactly how the valve is seated. The patients have come off bypass without any difficulty, excellent gradients, good cardiac outputs and good ventricular function.”
Svensson added, “With other valves if you break a suture you’re basically committed to taking the valve off and out. Here there are no leaflets, so it’s very easy to see and put in extra sutures.”
The company will now pursue clinical trials in Europe, which allows the most straightforward and predictable regulatory approval pathway. Clinical trials are expected to begin in early 2012 with European regulatory approval expected in late 2012 or 2013.
All ValveXchange heart valves are designed for long durability and leaflet exchangeability. The Vitality model, which has just been implanted in the FIM studies, is intended for the broad adult aortic valve marketplace.
The company also is developing the Vanguard series of transcatheter valves (for transapical and transfemoral implant). They are being designed to incorporate surgical valve-durability and the same leaflet replacement feature as the Vitality, but for the aged, non-surgical patient population.
For more information: www.valvexchange.com