FDA approves Metavention’s renal denervation for hypertension pivotal IDE study

The iRF renal denervation system. [Image from the Metavention website]Metavention announced today that the FDA granted approval to initiate an investigational device exemption (IDE) trial for its renal denervation system.

Minneapolis-based Metavention designed its integrated radiofrequency (iRF) renal denervation system to treat hypertension. The company plans for its randomized, double-blinded, sham-controlled RADAR study to enroll up to 300 patients across 50 centers. This pivotal study evaluates the safety and efficacy of the iRF renal denervation system.

Metavention designed its iRF denervation system to provide an important distinction to renal denervation procedures: it requires only a single ablation cycle per kidney. The company believes this approach could simplify procedures and reduce the overall burden on patients undergoing renal denervation.

The catheter-based, minimally invasive procedure uses an integrated, multi-RF electrode balloon. It als…

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Medical device VCs give long-term pandemic perspectives

In Episode 10 of DeviceTalks Weekly, we talk with two successful starters of medtech companies about how they’re building and maintaining their medtech portfolios during this pandemic landscape.

Our guests this week are Dr. Justin Klein, managing partner of Vensana Capital, and Duke Rohlen, chair of Ajax Health. Together, Klein and Rohlen have created, backed and sold medtech companies that have generated billions.

Klein, formerly of New Enterprise Associates, now co-manages his own venture firm, Vensana Capital. He previously served on the board of directors of Cartiva (acquired), ChromaCode, CV Ingenuity (acquired), EPIX Therapeutics (acquired), FIRE1, GPB Scientific, Intact Vascular, Metavention, Personal Genome Diagnostics, PhaseBio Pharmaceuticals (IPO), Relievant Medsystems, Senseonics (IPO), Topera (acquired), Ulthera (acquired), Vertiflex (acquired), Vesper Medical and VytronUS (acquired).

Rohlen, who leads a holdings company backed by private eq…

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