Monteris Medical won a regulatory nod in the U.S. and in Canada for its NeuroBlate MRI-guided tumor ablation device, the company said.
Investigational Device Exemption (IDE)
Invivo starts first human trial for spinal cord scaffold
InVivo Therapeutics (OTC:NVIV) said the FDA has given the company the green light to begin the first human clinical studies of its bioploymer scaffold, which treats traumatic spinal cord injury.
The Cambridge, Mass.-based company said it is gearing up for safety studies in 5 patients over 15 months, and is shooting for Institutional Review Board (IRB) approval at Massachusetts General Hospital.
Sorin’s cardiac resynchronization device wins conditional FDA approval
Sorin Group (BIT:SRN) said the FDA granted conditional approval for an investigational device exemption for its SonR cardiac resynchronization device.
The Italian medical device company said it will launch the Respond CRT trial to evaluate the SonR device in more than 1,000 U.S. patients with advanced heart failure.
InVivo updates bid for FDA OK of spinal trauma treatment
InVivo Therapeutics (OTC:NVIV) hopes to begin testing in humans in an open-label safety and efficacy study now that it’s updated its submission for an investigational device exemption submission for its spinal cord injury treatment.
InVivo filed the original investigational device exemption application in July 2011, but has yet to be approved.
Biotronik gets FDA go-ahead for MRI-safe pacemaker trial
The FDA approved a clinical trial of Biotronik‘s Entovis MRI-safe pacemaker, granting an investigational device exemption to the German medical device company.
Biotronik said it’s already enrolling subjects for the 245-patient trial, which will aim to determine the safety and efficacy of the device during MRI scans.
Thoratec lands FDA win for HeartMate II trial
Medtronic’s Endurant III graft looks good at 2 years
Medical device giant Medtronic (NYSE:MDT) touted positive 2-year findings for its popular Endurant AAA stent graft system, vindicating previous findings.
Medtronic presented the new data, compiled from a U.S. investigational device exemption study and an international ENGAGE registry of Endurant AAA patients, at the VEITHsymposium in New York this week.
Abiomed wins FDA nod for Impella trial
Biotronik touts IDE approval, 1st implant for Pulsar-18 stent in Bioflex-I trial
Cardiovascular medical device maker Biotronik touted FDA investigational device exemption for and 1st U.S. implantation of its Pulsar-18 self-expanding stent, the latest in the company’s line of peripheral artery stents.
The FDA approval granted the Lake Oswego, Ore.-based company approval to add U.S. patients to its prospective, non-randomized study of the Pulsar-18 stent in the BioFlex-1 trial, which also includes centers in Europe and Canada, according to a press release.
Kips Bay lands FDA approval to begin eSVS mesh study
Kips Bay Medical (NSDQ:KIPS) won conditional FDA investigational device exemption approval for its eSVS mesh, allowing the company to begin a clinical study of the device in use during coronary artery bypass procedures.
Stentys lands FDA nod to launch 1st U.S. trial with novel Self-Apposing stent
Stent maker Stentys SA (EPA:STNT) won FDA investigational device exemption to launch its 1st U.S. clinical trial of its Self-Apposing stent that it hopes to use in support of a premarketing approval bid.
The announcement was made as the company, in a separate release, unveiled interim results of its Apposition III trial during the Transcatheter Cardiovascular Therapeutics conference in Miami this week.