ROX Medical, Inc.
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Results Recap: CRT In DC Features New Biotronik Stent Data, Encouraging TAVR Low-Risk Data; Ablative Systems’ Alcohol Renal Denervation
Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition, covering March 1 to March 7, includes results of late-breaking trials presented at the 2019 Cardiovascular Research Technologies (CRT) conference in Washington, DC, including new data supporting Biotronik’s biodegradable polymer sirolimus-eluting stent and the company’s resorbable magnesium stent, results of the LRT trial of transcatheter aortic valves in low-risk patients, plus promising clinical data supporting Ablative System’s alcohol renal-denervation system.
Despite industry-wide contraction last year after Medtronic's SYMPLICITY, some believe a hypertension device is just around the corner. With a market estimated in the billions or even tens of billions of dollars, both Medtronic and Boston Scientific are launching redesigned studies, and a determined handful of medtech start-ups continue to pursue a device-based solution for treating hypertension with invasive and noninvasive approaches, including renal sympathetic denervation through radiofrequency, ultrasound, or drugs; neuromodulation in the forearm; and cold therapy to specialized cells in the neck.
Despite industry-wide contraction last year after Medtronic's SYMPLICITY, many agree the trial was flawed, and some believe a hypertension device is just around the corner. A determined handful of medtech start-ups continue to pursue a device-based approach, most by reducing “fight-or-flight” outflow from the sympathetic nervous system.
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.
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Surgical Equipment & Devices
- Minimally or Less Invasive