Clinical Trials
PAD: Shockwave Medical touts 6-month data
Biotronik looks to get into the TAVI game
Biotronik today said its entry into a hot replacement heart valve market passed the safety endpoint of a 1st-in-human trial.
The German medical device giant said the Biovalve trial of its transcatheter aortic valve implant established the device’s early safety at 30 days.
ImThera begins pivotal trial for Aura6000 sleep apnea implant
ImThera Medical said the 1st 2 U.S. patients in a clinical study of its Aura6000 sleep apnea therapy were successfully implanted with the device. The surgeries were performed by Dr. Sam Mickelson of Advanced Sleep Centers in Atlanta, Ga.
FDA OKs trial for StimGuard’s bladder implant
StimGuard said it won an investigational device exemption from the FDA for a clinical trial of its micro-size implantable device to treat overactive bladder syndrome. StimGuard said its system uses a small injectable microchip and an external transmitter and requires no invasive surgery to implant. The trial is slated to begin in summer 2015.
Sanuwave trial board wants more data
Sanuwave Health (OTC:SNWV) said the oversight board for a clinical trial of its DermaPace diabetic foot ulcer treatment wants more data after determining that the trial is unlikely to meet its primary endpoint.
PAD: Intact Vascular touts 1st-in-human results
Intact Vascular said a 1st-in-human study of a device designed to repair arterial dissections after angioplasty has produced encouraging results.