Work With Patients To Design Trials For Anti-Hypertensive Devices, FDA Advisors Suggest
FDA is looking forward to reviewing PMAs from several anti-hypertension devices in the coming years – including technologies from Medtronic, ReCor Medical, ROX Medical, and Vascular Dynamics – so the agency convened its Circulatory System Devices Panel on Dec. 5 to get recommendation on pre-market clinical trial design, post-approval study design, indications and labeling for such devices.
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The 50-patient SPYRAL DYSTAL trial will evaluate the benefits of a new targeted renal denervation approach with the Symplicity Spyral renal denervation system in patients with uncontrolled hypertension.
Results Recap: CRT In DC Features New Biotronik Stent Data, Encouraging TAVR Low-Risk Data; Ablative Systems’ Alcohol Renal Denervation
Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition, covering March 1 to March 7, includes results of late-breaking trials presented at the 2019 Cardiovascular Research Technologies (CRT) conference in Washington, DC, including new data supporting Biotronik’s biodegradable polymer sirolimus-eluting stent and the company’s resorbable magnesium stent, results of the LRT trial of transcatheter aortic valves in low-risk patients, plus promising clinical data supporting Ablative System’s alcohol renal-denervation system.
FDA has set a panel meeting date in December that will include discussion of trial designs and potential indications for devices being developed to treat hypertension. Also, the advisory panel will look at an implantable device seeking approval for use in heart-failure patients.