FDA grants breakthrough device designation for two renal denervation devices as companies race to be first on the market

GlobalData Healthcare 24 December 2020 (Last Updated December 24th, 2020 09:17)

FDA grants breakthrough device designation for two renal denervation devices as companies race to be first on the market
Between 2009 and 2010, renal denervation was considered to be one of the most groundbreaking medical treatments discovered, potentially offering a solution for the largely untreated hypertensive population. Credit: Davizro Photography/Shutterstock.

On 9 and 11 December 2020, SoniVie and ReCor Medical both received FDA breakthrough device designation, for their TIVUS and Paradise Renal Denervation Systems, putting these two companies ahead of the race to enter the renal denervation market.

Resistant hypertension is a form of hypertension where, despite being treated with three or more antihypertensive medications, the patient’s systolic blood pressure remains over 140 mmHg. GlobalData estimates that by the end of 2020, almost 12 million people in the US will have resistant hypertension and this is expected to grow by a compound annual growth rate (CAGR) of almost 4% over the next 10 years.

Between 2009 and 2010, renal denervation was considered to be one of the most groundbreaking medical treatments discovered, potentially offering a solution for the largely untreated hypertensive population. While some devices received CE approval, renal denervation was not approved in the US. In 2014, results from Medtronic’s Simplicity HTN-3 clinical trial, the largest and most rigorously designed study on renal denervation, did not meet its primary or secondary efficacy endpoints, causing a global downturn in the market.

This market still demonstrated tremendous opportunity as companies continued to improve their existing devices in order to be the first manufacturer to open up the market again. GlobalData estimates that almost 90% of resistant hypertensive patients are undergoing some form of treatment. With few manufacturers in the field and a market opportunity of almost 10 million hypertensive patients each year, the breakthrough designation puts ReCor Medical and SoniVie far ahead of larger manufacturers such as Medtronic.

GlobalData expects that given the prospects of the renal denervation market, both manufacturers would also be prime acquisition targets for larger manufacturers looking to enter the space.