Medtronic Marches Ahead In Renal Denervation; Announces Symplicity’s Inclusion In US Parallel Review Program
Medtronic’s Symplicity renal denervation system has won entrance into an elite group – it is one of the first devices to be selected for the joint FDA/CMS parallel review program, launched in 2011. That distinction could help the company quickly move the device into US clinical practice once it’s FDA approved.
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Medtronic and Boston Scientific are getting set to launch new trials of their renal denervation technologies, both believing they can overcome the problems that caused Medtronic's SYMPLICITY HTN-3 sham-controlled trial to miss its primary endpoint last year.
With the recent success of Ardian’s Symplicity Renal Denervation System, drug-resistant hypertension has emerged as something of a device market “gold rush.” Some observers estimate there are now as many as 40 companies developing various device-based therapies for resistant hypertension, including most of the big names in the cardiovascular device arena – Medtronic, St. Jude Medical, Boston Scientific, Johnson & Johnson, and Covidien PLC – along with a number of start-ups, all of which are racing to stake a claim in this highly promising market. Only time will tell which companies will be successful – even Medtronic, the first player, has yet to complete its sham-controlled US trial. But the technology’s early promise, along with the sheer size of the opportunity and the acute unmet need, clearly have peaked the interest of investors, manufacturers, and physicians alike, all of whom are chasing after what one participant has called “the next biggest thing in cardiology.”
SK Bioscience has received the world’s first approval of its in-house developed recombinant protein COVID-19 vaccine SKYCovione (GBP510), in its home market of South Korea, two years after it began development. Strong support from the domestic government and international cooperation helped pave the way.