Medtronic ($MDT) isn't wasting any time in the renal denervation world, completing a feasibility study of the next generation of its Symplicity device for drug-resistant hypertension--one that looks a whole lot like cross-town rival St. Jude Medical's ($STJ) EnligHTN.
The original Symplicity uses a single electrode to deaden nerves in the kidneys, and the new model has four, aiming to reduce procedure time for patients. In a first-in-man study of 9 patients, Medtronic says the multi-electrode model performed with 100% acute success rate.
EnligHTN, also already on the market overseas, has had four electrodes since the get-go.
Medtronic was the first on the scene with Symplicity, and it leads the way on the path to FDA approval, but St. Jude has long held that its multi-electrode method is considerably faster and twice as effective in lowering blood pressure among hypertensive patients. When St. Jude touted EnligHTN's clinical results, Medtronic dismissed them as "interesting" but merely "hypothesis-generating."
It would appear that the device giant has changed its tune, however, as the next generation of Symplicity emulates St. Jude's approach, and Medtronic touts it as "designed to significantly reduce ablation time during renal denervation procedures." While it's not an implicit endorsement of EnligHTN's engineering, Medtronic's move suggests the company is looking soberly at how best to stay atop the renal denervation market as more players enter the fray.
Medtronic is in the midst of a large-scale IDE study for Symplicity, looking to get FDA approval in 2015. After that, the company will presumably go the 510(k) route to get the multi-electrode model cleared for use. By then, it may face a crowded market, as Covidien ($COV), Vessix Vascular and ReCor Medical are expected to approach the FDA once word comes down on Symplicity.
- read Medtronic's release
Special Report: Renal Denervation - The Next Big Thing in Medical Devices
Like what you're reading?
Click here to get more news like this delivered to your inbox every day >