Boston Scientific Corp.’s Lotus device, inserted through a catheter into the heart to fix a damaged aortic valve, was safely implanted without any severe leakage in a study being conducted for European approval.
The findings presented at the EuroPCR meeting in Paris showed the Lotus device improved blood flow through the repaired aortic valve, without complications such as the need for by-pass surgery. One of the 60 patients developed moderate regurgitation around the valve, which has been tied to a higher risk of death, while 79 percent had little to no leakage. Almost 30 percent needed a pacemaker after treatment.
The valve from Natick, Massachusetts-based Boston Scientific would compete against devices from Medtronic Inc. and Edwards Lifesciences Corp. if it wins European approval. It has a feature known as the Adaptive Seal that was designed to minimize the paravalvular regurgitation risk. It also can be moved as physicians find the best spot to deploy the valve, or pulled out of the heart entirely if needed to ensure the best result. Edwards sells the only catheter-based valve in the U.S.
“This is a game-changer because all the first generation devices aren’t repositionable when fully deployed,” said researcher Ian Meredith, director of Monash Heart at Monash Medical Centre in Melbourne. “There comes a point in the procedure where you have to let the valve go. With Lotus, you have almost obliterated the likelihood of regurgitation and at the same time given extreme control to the operator to get the valve positioned in exactly the right place.”
The very low rates of leakage around the valve should help Boston Scientific market the device, even though the number of patients needing pacemakers was high, said Danielle Antalffy, an analyst at Leerink Swann in New York, in a note to investors. Getting less leakage in exchange for higher pacemaker rates than with Edward’s Sapien XT valve is “a trade-off we suspect many physicians will be willing to accept,” she said.
“Based on the data we saw today, we expected Boston Scientific will be able to gain CE mark approval in Europe in the second half of 2013 and compete primarily against Edwards and Medtronic, who currently split the market,” she wrote.
Boston Scientific is expected to begin the studies needed for U.S. approval of Lotus sometime next year.
Boston Scientific declined 1.1 percent to $9.13 at the close in New York. The shares gained 54 percent in the past 12 months.