ReCor Medical announced that an FDA panel has voted in favor of the safety and efficacy of its Paradise ultrasound renal denervation (RDN) system for treating hypertension. On Aug. 22, the Circulatory Systems Devices Panel of the FDA’s Medical Devices Advisory Committee voted 12–0 in favor with regard to safety and 8–3 in favor, with […]
ReCor Medical
FDA review panel: Medtronic Symplicity Spyral RDN risks outweigh benefits
An FDA review panel voted against recommending approval of Medtronic’s Symplicity Spyral renal denervation (RDN) therapy for hypertension under the proposed indications. The panel unanimously said the minimally invasive catheter system is safe, but was nearly split on efficacy. With six members voting that the benefits outweighed the risk, six voting the other way and […]
ReCor Medical is pleased with updated renal denervation guidelines in Europe
ReCor Medical today applauded updated and expanded recommendations for managing arterial hypertension overseas. The European Hypertension Society (ESH) this month issued updated guidelines on the role of renal denervation in the hypertension care pathway. It announced the guidelines at the ESH 32nd Annual Meeting and simultaneously published them in the Journal of Hypertension. These new guidelines serve […]
ReCor Medical announces more positive study results for its renal denervation system
ReCor Medical announced today that its Paradise ultrasound renal denervation (uRDN) system successfully reduced blood pressure in a study. Palo Alto, California-based ReCor published primary endpoint results from its Radiance II trial in the Journal of the American Medical Association (JAMA). Results showed success for Paradise in reducing blood pressure compared to sham. Additionally, pooled analysis […]
ReCor Medical names Siemens Healthineers, Terumo veteran as CEO
ReCor Medical today announced it appointed Lara Barghout as president and CEO. Barghout will succeed Andrew Weiss. She will lead the Palo Alto, California-based company’s business strategy and organization in a new direction, according to the company. The goal is to commercialize ReCor’s Paradise ultrasound renal denervation (uRDN) system that treats hypertension. “I am honored […]
ReCor reports more positive ultrasound renal denervation results
ReCor Medical said its Paradise ultrasound renal denervation (uRDN) treatment showed consistent and significant blood pressure reductions in an analysis of pooled data from ReCor’s three Radiance randomized hypertension studies. “Pooling the data from the Radiance program demonstrates that treatment with the Paradise uRDN System results in a consistent reduction in blood pressure across differing […]
4 major cardiology trends you need to know from TCT 2022
Medtronic, Edwards and Abbott presented positive data as TAVR, TEER and renal denervation innovations continue to arrive. The 34th Transcatheter Cardiovascular Therapeutics (TCT) conference took place in Boston this past week and a ton of big names made waves with their technologies and innovations. Medtronic, Abbott, Edwards and Boston Scientific represent a few of the […]
ReCor Medical ultrasound renal denervation trial meets primary efficacy endpoint
ReCor Medical announced that a trial for its Paradise ultrasound renal denervation (uRDN) treatment met its primary efficacy endpoint. Palo Alto, California-based ReCor’s RADIANCE II pivotal trial evaluated Paradise as a treatment for hypertension. The trial operated under FDA investigational device exemption. ReCor presented results at TCT 2022 in Boston. They follow the company’s July […]
ReCor Medical, Otsuka say renal denervation system met primary endpoint in U.S. study
ReCor Medical and Otsuka Medical Devices today announced positive results from a trial of its renal denervation system for hypertension. The Radiance II U.S. FDA investigational device exemption (IDE) pivotal trial evaluating the Paradise ultrasound renal denervation (uRDN) system as a treatment for hypertension met its primary efficacy endpoint, demonstrating a statistically significant reduction in […]
ReCor Medical completes enrollment in renal denervation trial for treating hypertension
ReCor Medical announced today that it completed enrollment in its Radiance-II pivotal trial of the Paradise ultrasound renal denervation (uRDN) system. The Radiance-II trial of the Paradise uRDN system will evaluate the platform in the treatment of uncontrolled hypertension in patients on zero-to-two antihypertensive oral medications. ReCor Medical designed its Paradise platform as a device-based, […]
ReCor Medical’s ultrasound renal denervation system launches in Europe
ReCor Medical announced today that it launched its Paradise ultrasound renal denervation system in Germany. Palo Alto, California-based ReCor said in a news release that it made its Paradise system available for treating uncontrolled hypertension, with Heart Center Leipzig and Saarland University Hospital (Homburg/Saar). The company designed its Paradise platform as a device-based, minimally invasive […]
