The clinical trial of Lotus replacement heart valve from Boston Scientific Corporation (NYSE:BSX) produced promising results compared to CoreValve from Medtronic. Data presented at an industry annual EuroPCR meeting in Paris outlined that Boston’s device was way ahead in terms of meeting efficacy endpoints. The one-year long Reprise III study, which involved 912-patients, compared the two devices in high- and extreme-risk patients.
The Lotus valve demonstrated superiority on the efficacy endpoint
The Lotus valve system had excellent performance according to global CMO Dr. Ian Meredith. It presented a crucial piece of clinical evidence of its safety and efficacy, having obtained a 16.7% against the 29.0% from the CoreValve arm. It was at 2.0% at the secondary endpoint while its rival got 11.1%.
The primary safety endpoint was primarily targeting life-threatening and major bleeding, whereby the leakage around the edges of the Lotus valve was found to be lower. It was also a composite rate of all-cause mortality and major vascular problems. Lotus valves are yet to receive an approval from the FDA even though they proved non-inferior. Nonetheless, the applause of results by analysts may mean an approval for the heart device later in the year is likely
Only two companies’ devices are approved for the U.S. market
It is worth noting that the differences in performance were primarily brought about by the contrasts in leakage around the valve as well as the disabling stroke. However, Medtronic did not agree with the finding on disabling strokes. A spokesman for the company claimed that the stroke statistic was “probably a chance finding”.
On the contrary, Reprise III investigator Dr. Ted Feldman notes, “The excellent results seen in this large randomized trial, particularly the superior performance in efficacy and the continued demonstration of low PVL rates, further establish the advantages of the Lotus valve system.”
There are only two devices that have been approved in the US market. They are Sapien valve system from Edwards Lifesciences and Medtronic’s CoreValve. The presence of a third market is likely to create stiff competition but on the other hand, it has been embraced by a majority of Doctors.
In the meantime, BSX’s stock closed at $26.48 witnessing an increase of $0.06 or 0.23% while that of MDT was trading at $83.94 a fall of $0.20 or 0.24%.