Marlborough, Mass.-based Boston Scientific touts the Lotus is the first transcatheter aortic valve implant that is both fully repositionable and retrievable prior to release. Stenosis is a condition in which a patient suffers abnormal narrowing of a blood vessel; aortic valve stenosis affects about 3% of the population age 65 and older, and 5% of people older than 75, according to data cited by Boston Scientific. The average survival rate is 50% at 2 years and 20% at 5 years, the company said.
This week a team led by Dr. Ted Feldman of NorthShore University HealthSystem in Evanston, Ill., implanted 3 Lotus valves as part of the Reprise III trial, according to a press release.
"New data from Reprise I and Reprise II, which were presented last week at TCT 2014 in Washington, D.C., demonstrate remarkably low rates of paravalvular leakage and all-cause mortality," Feldman said in prepared remarks. "We believe that Reprise III, which is slated to involve more than 1,000 patients, will confirm these data and show that the Lotus Valve System has the potential to improve patient outcomes beyond what we’ve seen with first generation devices."
The Lotus system consists of a pre-loaded, stent-mounted tissue valve prosthesis and catheter delivery guidance system. The system is designed to enable bidirectional repositioning and retrieval at any time prior to release of the aortic valve implant. The device also features what Boston Scientific says is a unique adaptive seal to minimize the incidence of blood leaking between the valve and tissue, which can cause cardiac arrest.
Boston Scientific won CE Mark approval in the European Union last year for the Lotus TAVI.
"Our structural heart franchise continues to build momentum and strengthen internationally," CEO Michael Mahoney said in a July conference call. "We believe that 6 months post-Lotus TAVI launch, we are now the number 3 transfemoral aortic valve company in Europe."
Boston Scientific sales of interventional cardiology products totaled $528 million in the 2nd quarter, up 2% from the year before, making up 28% of total sales.