California-based ReCor Medical wasn’t deterred by the tumult in renal denervation following Medtronic’s (NYSE:MDT) disappointing clinical trial, vowing to proceed with commercial efforts for its Paradise System for treating hypertension.
ReCor’s technology uses ultrasound rather than radiofrequency energy, and the company deemed its system sufficiently different from Medtronic’s and others to merit continued progress.
"Having reviewed our own clinical results and spoken to clinicians who have collectively treated hundreds of patients with resistant hypertension using different RDN systems, ReCor is convinced that our product is well-differentiated from these RF-based approaches," ReCor president & CEO Andrew Weiss said in prepared remarks. "We remain convinced that RDN has the potential to become a key component of HTN therapy, and believe that our Paradise System provides the safe, reliable and complete denervation needed to become the category leader in this field."
ReCor just last month won CE Mark approval in the European Union, with the 1st patients already treated in Germany, and the company also announced initial use of its Radiance line of radial-access-friendly catheters.
The Paradise System is the only CE Marked renal denervation system using ultrasound energy, with rival devices from Medtronic, Boston Scientific (NYSE:BSX) and St. Jude Medical (NYSE:STJ) all using radiofrequency energy to ablate the nerves lining the renal arteries, which are believed to contribute to hypertension.
Hopes for the renal denervation market plunged earlier this month with the surprise announcement that the U.S. trial for Medtronic‘s (NYSE:MDT) Symplicity RDN device missed its primary efficacy endpoint. Full results from the trial are slated to drop at the American College of Cardiology conference in late March. The news came as a shock to the industry; an FDA nod for the Symplicity device once seemed to be such a lock that St. Jude suspended a U.S. trial of its Enlightn renal denervation entry.
Both St. Jude and Boston Scientific, which got into RDN with the $130 million buyout of Vessix last year, said last week that they were still bullish on the technology in hard-to-treat high blood pressure cases. But Boston still decided to delay the Vessix program until more is known about the Symplicity miss, CEO Michael Mahoney said.
Last week Covidien (NYSE:COV) announced that it would wind down development of its OneShot renal denervation device, which already had E.U. regulatory approval, meaning the closure of Covidien’s Rapid II trial.
Registration is open for DeviceTalks Boston! Join us on June 5-6, 2019, as we explore the trends and technology that are shaping the future of the medical device industry.