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 […]
renal denervation
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 […]
Medtronic applauds new renal denervation guidelines in Europe
Medtronic issued a statement highlighting its excitement over new renal denervation guidelines in Europe. The European Hypertension Society (ESH) 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. Medtronic said in […]
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 […]
Medtronic RDN trial fails to beat hypertension drugs; data submitted for FDA review
Medtronic (NYSE:MDT) said its Symplicity Spyral renal denervation (RDN) system for treating hypertension failed to outperform blood pressure drugs in the latest trial results. However, the SPYRAL HTN-ON MED clinical trial’s six-month results did show improvement over Medtronic’s previous RDN efforts, the device maker said in a news release. RDN is designed to treat hypertension […]
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 […]
Study shows blood pressure reduction with Medtronic renal denervation procedure
Medtronic (NYSE:MDT) announced study data that it says demonstrates significant blood pressure reduction with the Symplicity renal denervation system. The SYMPLICITY HTN-3 clinical trial observed subjects who underwent radiofrequency renal denervation (RF RDN) with first-generation Symplicity. Results demonstrated a statistically significant reduction in office and ambulatory blood pressure compared to a sham control group. Medtronic’s […]
Medtronic’s renal denervation system demonstrates better blood pressure control, time in range
Medtronic (NYSE:MDT) announced today that new data supports the use of its Symplicity Spyral renal denervation (RDN) system. As part of the medtech giant’s Spyral HTN global clinical program, three-year data from the Spyral HTN-ON MED and GSR-Define trials were presented at EuroPCR 2022 as late-breaking clinical trials demonstrating the benefit of the Symplicity blood […]
Medtronic releases new renal denervation results, closes trial enrollment
Medtronic (NYSE:MDT) today said its Symplicity Spyral renal denervation (RDN) system demonstrated durable, clinically significant blood pressure reductions through three years for patients on medication. It’s the latest development out of Medtronic’s Spyral HTN-ON MED trial testing the company’s RDN catheter system, which delivers radiofrequency energy to overactive nerves near the kidneys that cause high blood pressure. […]