Boston Scientific (NYSE:BSX) presented 1-year data from its Reprise II clinical trial of the Lotus transcatheter aortic valve implant this week at the Transcatheter Cardiovascular Therapies conference in Washington, saying the repositionable Lotus valve showed low rates of paravalvular leakage after implantation.
Reprise II is a single-arm, prospective trial involving 120 patients with aortic stenosis that are at high risk for open heart surgery. Marlborough, Mass.-based Boston Scientific said the 12-month data showed that more than 86% of patients had no leakage around the valve and no patients showed moderate or severe paravalvular leakage.
The cardiovascular mortality rate was 6.7% and the disabling stroke rate was 3.4%, according to a press release. Two-year data from Reprise I also showed no instances of moderate or severe paravalvular leakage and no deaths, the company said.
"The 1-year Reprise II data show strong and sustained clinical benefits, excellent valve hemodynamics and remarkably low rates of paravalvular regurgitation and cardiovascular mortality," principal investigator Dr. Ian Meredith of the Monash Medical Centre in Melbourne, Australia, said in prepared remarks. "These positive data reinforce the benefits and features of the Lotus valve system including the ability to achieve precise primary valve placement, reposition or fully retrieve if needed, and minimize if not obliterate paravalvular regurgitation with an effective Adaptive Seal."
"We are pleased that these Reprise I and II data demonstrate excellent and sustained results with no moderate or severe paravalvular aortic regurgitation," added Boston Scientific chief medical officer Dr. Keith Dawkins. "The Lotus valve system, with its unique technology, has the potential to address an unmet need and improve clinical outcomes for patients with severe aortic stenosis."
TAVI devices are center-stage at TCT 2014 with the latest data dumps from market leaders and arch-rivals Edwards Lifesciences (NYSE:EW) andMedtronic (NYSE:MDT) showing clear benefits for transcatheter aortic valve implants and a shocker from St. Jude Medical (NYSE:STJ).