The annual Transcatheter Cardiovascular Therapeutics conference is under way in Washington, D.C., with late-breaking study results beginning Oct. 29. We’ll update this post throughout the day as new results come in, so be sure to check back for the latest news out of TCT 2016. After stents took center stage Day 1, with a raft of […]
Claret Medical Inc.
Claret Medical files for FDA clearance for Sentinel cerebral protection device
Claret Medical said today that it filed an application with the FDA seeking 510(k) clearance for its Sentinel cerebral protection system designed for use during transcatheter aortic valve replacements. The Santa Rosa, Calif.-based company’s Sentinel device is designed to capture and remove embolic debris dislodged during TAVR procedures, which can enter cerebral circulation and can potentially lead […]
TAVR: Study shows benefit of Claret Medical’s Sentinel cerebral protection device
A study released this week reported that the use of Claret Medical’s cerebral protection device during transcatheter aortic valve implantation procedures in patients with severe aortic stenosis can reduce the number and volume of brain lesions. The study, which received funding from Claret and Medtronic (NYSE:MDT), was published in the August 9 issue of the The […]
TAVI: Claret Medical launches U.S. trial
Claret Medical said today that the 1st patient has been treated in a U.S. pivotal trial of its Sentinel cerebral protection system, which is designed to guard against stroke during transcatheter aortic valve implantation.
Abiomed touts survival rates for its Impella right-side heart pump | TCT 2014 Roundup
Abiomed (NSDQ:ABMD) got some Wall Street love today after releasing positive outcomes from a clinical trial of its minimally invasive Impella Right Percutaneous heart pump.
Researchers reported an overall 73% 30-day survival rate in the small study of patients with right ventricular heart failure, according to data Abiomed released during the Transcatheter Cardiovascular Therapeutics conference in Washington D.C.
TAVI: Claret Medical closes enrollment in brain defense study
Updated Sept. 5, 2014, at 11:00 a.m. EST.
Claret Medical announced this week that it enrolled the final patient in a European clinical trial as it chases FDA approval for its Sentinel cerebral protection device.*
Claret Medical chases FDA win with $18M Series B for cerebral protection device
Claret Medical said today that it secured up to $18 million in Series B financing it plans to use to make progress toward the U.S. market.
Claret Medical lands FDA OK for U.S. trial of Sentinel cerebral protection device
Claret Medical is clear to launch a pivotal U.S. trial of its Sentinel cerebral protection system, having won FDA approval to evaluate the device in patients undergoing transcatheter aortic valve implantation.
The study is slated to begin in the 1st quarter of 2014 and will involve up to 15 clinical centers, Claret reported.
Claret Medical lands CE Mark for Sentinel device
Claret Medical’s Sentinel cerebral protection system won CE Mark approval for use providing protection against embolism during transcatheter aortic valve replacement.
The Sentinel uses a filter-based system to remove potentially dangerous embolic debris that may be dislodged during a TAVI procedure, preventing the debris from traveling to the brain. Claret plans immediately to put the device on the market, according to a press release.
TAVI: Claret Medical asks FDA to approve Sentinel trial
Claret Medical said it filed asked for an investigative device exemption from the FDA for a clinical trial of its Sentinel cerebral protection system.
Santa Rosa, Calif.-based Claret wants to conduct a multicenter study using the Sentinel for embolic protection during transcatheter aortic valve implantation, comparing use of the Sentinel device with standard care.
Claret Medical raises $3.6M through private offering
Updated July 8, 2013, at 5:30 a.m. company updates. The funds were raised through a private offering of convertible promissory notes.
California-based medical device maker Claret Medical has raised $3.6 million so far through a private offering, company officials confirmed with MassDevice.com.