It was a big week for Medtronic (NYSE:MDT) and its Symplicity high blood pressure device, with the release of 2-year clinical data and a pair of regulatory developments for the renal denervation system.
The Fridley, Minn.-based medtech titan said 2-year data from its Symplicity HTN-2 trial showed that 40 patients who received the Symplicity treatment "sustained a significant drop in blood pressure," with no device-related serious adverse events, no late vascular complications and no significant decline in kidney function.
Medtronic also said that the Symplicity device is 1 of the 1st to be accepted into a dual regulatory and reimbursement pathway with the FDA and the Centers for Medicare & Medicaid Services, allowing to pursue a green light from the federal watchdog agency while CMS reviews Symplicity for a possible national coverage decision.
And Medtronic said it’s asked the FDA for an investigational device exemption for the Symplicity HTN-4 trial of patients with resistant hypertension.
Abbott updates MitraClip data
Abbott (NYSE:ABT) said new data from the EVEREST II trial of its MitraClip mitral regurgitation device, from the study’s high surgical risk cohort, showed that 351 U.S. patients showed a "significantly lower" 30-day mortality rate, a low rate of adverse events and an implant success rate of 96%.
STENT WARS: Medtronic, Abbott, Stentys and Terumo
Data from the global registry for Medtronic’s nearly 5,000-patient Resolute drug-eluting stent showed that patients who interrupted dual antiplatelet drug therapy a month after stent deployment "showed no increased safety risk through 1 year of follow-up."
Not to be outdone, rival Abbott said a study of its Absorb bioresorbable stent showed "the rate of major adverse cardiovascular events in 101 patients was 10% at 3 years, similar to a comparative set of data with a best-in-class drug eluting stent at the same follow-up period."
Stentys SA (EPA:STNT), which is developing what it claims is the 1st and only "self-apposing" stent, said 1-year results from the APPOSITION III clinical trial of 1,000 patients showed a MACE rate of 9.3%, compared with 11.1% for "conventional stents," and a cardiac death rate of 2.0% (vs. 3.9%).
And a study comparing the Nobori stent made by Japan’s Terumo Corp. (TYO:4543) with Boston Scientific‘s (NYSE:BSX) Promus DES showed that the Nobori device and its biodegradable biolimus coating was statistically comparable with the Promus device, the top DES on the Japanese market.
Positive results from Cardiovascular Systems’ ORBIT II send shares up 18%
Shares of Cardiovascular Systems (NSDQ:CSII) soared 17.6% yesterday after the medical device company presented what 1 analyst called "convincingly positive" 30-day data from the ORBIT II trial of its atherectomy device. CSII shares were trading at $19.41 as of about 11:20 this morning, compared with their $16.50 closing price March 8. Leerink Swann analyst Danielle Antalffy said the data could augur for FDA approval of the device during the 1st quarter of 2014.