Boston Scientific (NYSE:BSX) this week presented new data from the Respond extension study of its Lotus transcatheter aortic valve replacement with its Depth Guard technology, touting no deaths and low rates of paravalvular regurgitation.
Data from the study was presented at the Cardiovascular Research Technologies CRT 2017 annual meeting in Washington D.C.
The 50-patient Respond Extension study aimed to assess clinical and device performance outcomes with its Lotus Valve in combination with the Depth Guard technology.
The Marlborough, Mass.-based company’s Depth Guard tech is designed to optimize valve deployment by anchoring early during deployment and minimizing the depth of the valve frame. Reducing the depth reduces interaction with the left ventricular outflow tract and conduction system, and could reduce the need for new pacemaker implantation, the company said.
The primary endpoint for the Respond Extension trial are all-cause mortality at 30 days, with additional endpoints based on device performance, VARC-2 clinical efficacy and safety, new conduction disturbances and need for new pacemaker implantation and the grade of pre-discharge PVL.
Results from the trial indicated a 0% mortality rate upon discharge at 7 days. A total of 85.3% of patients in the trial reported no or trivial amounts of paravalvular leaks, while no moderate or severe PVLs were reported. Mild PVL was reported in 14.7% of patients.
Permanent pacemaker implantation at 7 days was 16% amongst all patients and 17.8% among pacemaker-naïve patients.
The company also presented data from the 1014-patient Respond post-market study of the valve, touting a 2.2% rate of all-cause mortality and 2.2% rate of disabling stroke at 30 days.
Of respondents in the trial, 92% had no reported paravalvular leaks at discharge, while 7.7% had mild leaks and 0.3% had moderate leaks. Permanent pacemaker implantation was at 30% at 30 days, according to the report.
In January, Boston Scientific had reportedly found a fix for its Lotus Edge heart valve after the company paused implantations of the device in October last year.
The company expects to submit a premarket application to the FDA in May, according to a Barclays report. The submission time would position Boston Scientific for approval by the end of the year, with a launch in early 2018.