Renal Denervation: Stepping Back To Move Forward
With the announcement that Medtronic is going back to the clinical drawing board after the pivotal SYMPLICITY HTN-3 trial of its renal denervation device failed to meet its primary efficacy endpoint, the industry is taking a cautious but still optimistic stance on the highly touted potential treatment for resistant hypertension.
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With Medtronic planning to submit an IDE application to the FDA soon to conduct a new US trial of its renal denervation technology, companies and investors alike remain optimistic about finding an effective device-based therapy for treatment-resistant hypertension. Two smaller players in this space – Rox Medical and Verve Medical – are also forging ahead, due to recently published encouraging study results for Rox’s stent-like implant, Coupler, and a nearly $2 million Series B1 round to fund further clinical trials of Verve’s Phoenix RF energy device.
Renal denervation with Medtronic’s Symplicity Flex catheter failed to significantly reduce systolic blood-pressure in a sham-controlled trial in patients with mild drug-resistant hypertension, although the per-protocol analysis did show a benefit from renal denervation.
Hanson Gifford III and Mark Deem, two co-founders of the prolific medtech incubator The Foundry, have had a hand in generating more than $2 billion in value for medtech investors and entrepreneurs during the incubator’s 15-plus years. At IN³ Medical Device 360° in Dublin, the pair shared some of the lessons they have learned along the way.