As the COVID-19 pandemic took over the world in 2020, medical device companies continued to showcase new catheter innovations. Throughout 2020, we saw FDA clearances, approvals and product launches for a variety of catheter-based technologies, including renal denervation systems, heart failure treatment catheters, mechanical thrombectomy systems and more. The list includes some medtech giants like […]
ReCor Medical
ReCor Medical gains FDA breakthrough nod for renal denervation system
ReCor Medical this week announced that its Paradise ultrasound renal denervation system won FDA breakthrough device designation following positive results in a study. The Palo Alto, Calif.-based company’s Paradise system is an investigational device that is designed to treat hypertensive patients who may not be sufficiently responsive to or are tolerant of anti-hypertensive medical therapy. […]
ACC 2019 Roundup – ReCor touts six-month Paradise renal denervation study results
ReCor Medical this week released “on-medication” results from the RADIANCE-HTN-SOLO clinical trial of its Paradise renal denervation system intended to treat uncontrolled hypertension, touting medication and blood pressure reductions at six months. Results from the trial was presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans and were simultaneously published […]
Otsuka to acquire renal denervation firm ReCor Medical
Otsuka Holdings (TYO:4578) said today that it plans to acquire the remaining stake it doesn’t already own in ReCor Medical and the renal denervation device it’s developing to treat hypertension. Tokyo-based Otsuka led ReCor’s $15 million Series D in April 2015 to back Palo Alto, Calif.- and Amsterdam-based ReCor’s Radiance-HTN study, which will test its Paradise system in patients […]
FDA approves ReCor Medical’s pivotal ultrasound denervation study
ReCor Medical said this week that the FDA approved a new pivotal study of the company’s Paradise ultrasound denervation system for the treatment of hypertension. The Palo Alto, Calif.-based company reported that its trial, Radiance-II, will be a randomized, sham-controlled study in patients with moderate hypertension. The study is designed to demonstrate the Paradise system’s […]
EuroPCR 2018 Roundup: Medtronic touts BP reductions, no major adverse events in renal denervation trial
Medtronic (NYSE:MDT) today released six-month results from a trial of its Symplicity Spyral renal denervation system exploring its use treating hypertensive patients who are already taking anti-hypertension medications, touting significant reductions in blood pressure and no major adverse safety events. Results were presented at the 2018 EuroPCR annual meeting in Paris and were published in The […]
ReCor Medical adds another $12m for trial of Paradise renal denervation device
ReCor Medical last week added a $12 million contribution from Otsuka Pharmaceutical (TYO:4578) to the $10 million it raised from the Japanese conglomerate last year for a clinical trial of its Paradise renal denervation device for treating hypertension, ReCor president & CEO Andrew Weiss told MassDevice.com this morning. In May 2016 Otsuka participated in a strategic investment of an unspecified amount; […]
ReCor pulls in $10m
Renal denervation device developer ReCor Medical raised $10 million in a new round of debt financing, according to an SEC filing posted today. The Palo Alto, Calif., and Amsterdam-based company is developing the Paradise renal denervation system designed to treat overactive nerves leading to the kidney through a minimally invasive surgery. The system uses a […]
Otsuka gets in on ReCor Medical’s Paradise renal denervation device
ReCor Medical said it landed a strategic investment from Japanese conglomerate Otsuka Pharmaceutical (TYO:4578) that will bring to Asia its Paradise renal denervation device for treating hypertension. Neither side is disclosing financial terms, but the deal calls for Otsuka to receive exclusive rights to pursue clinical trials, regulatory approval and commercialization of ReCor’s Paradise device in Japan, China, Korea […]
ReCor Medical launches trial for Paradise renal denervation device
ReCor Medical said today that it’s enrolled the 1st patients in the 292-patient Radiance-HTN study of its Paradise renal denervation device for treating hypertension. The blinded, randomized and sham-controlled trial is designed to evaluate the Paradise system in patients with essential hypertension taking 2 or fewer medications and patients with treatment-resistant hypertension on a minimum of 3 drugs. The trial […]
ReCor Medical to launch U.S. trial for Paradise renal denervation device
ReCor Medical said today that it won an investigation device exemption from the FDA for a clinical trial of its Paradise renal denervation device for treating high blood pressure. Palo Alto, Calif., and Amsterdam-based ReCor said the 292-patient Radiance-HTN study, a blinded, randomized and sham-controlled trial, is designed to evaluate the Paradise system in patients with essential hypertension […]
