Hypertension Devices Will Get US FDA Panel Focus
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.
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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.
Certain VCs are becoming reluctant to invest in medtech, citing difficulties such as a shrinking pool of buyers and increasing regulatory challenges. But Sofinnova Partners has successfully sold a medical device portfolio company – and one that is in a difficult field like renal denervation, no less – to a Japanese buyer. Antoine Papiernik, managing partner at the French VC, explains how persevering with a renal denervation technology paid-off and gives his perspective on whether medtech is still a space worth investing in.
Medtronic looks to be back on track with its renal denervation plans, after announcing its Symplicity Spyral system got off to a good start with positive six-month results in the SPYRAL HTN-ON MED pilot study. The data, presented at EuroPCR 2018 in Paris, showed that Symplicity Spyral was able to reduce blood pressure significantly in hypertensive patients prescribed anti-hypertension medications, with no major adverse safety events out to six months.