LoneStar Heart wins CE Mark for hydrogel heart implant
October 1, 2014 by Alex Soule
Laguna Hills, Calif.-based LoneStar Heart said it won CE Mark approval in the European Union for its Algisyl-LVR hydrogel implant for the treatment of advanced heart failure.
Algisyl-LVR is designed to reverse heart failure progression in patients with an enlarged left ventricle, according to a press release. Surgically injected directly into the heart muscle, the hydrogel acts as an internal scaffold that does not undergo long-term degradation and increases cardiac output, LoneStar Heart said. Read more
FDA launches cybersecurity initiative
October 1, 2014 by Alex Soule
The FDA is asking medical device manufacturers to submit documentation about cybersecurity controls they have in place to mitigate the threat of hackers accessing devices, including ongoing software patches and updates to operating systems.
The FDA issued the recommendations in a document to be released in full Thursday titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” after having released a draft version last June. On Tuesday, the agency stated it found no indication that specific devices or systems have been purposely targeted by hackers, but remains concerned about device-related cybersecurity vulnerabilities. Read more
TAVI: Direct Flow Medical wins CE Mark for enhanced heart valve delivery device
October 2, 2014 by Alex Soule
Direct Flow Medical today said it’s putting an enhanced delivery system for its replacement heart valve on the European market after it won CE Mark approval for use in patients at extreme risk for open heart surgery.
Santa Rosa, Calif.-based Direct Flow said the enhanced transfemoral delivery system for its transcatheter aortic valve implant features an ergonomic handle designed for easy, precise and controlled delivery of the valve and includes a low-profile, flexible sheath for easy access and better tracking through calcified tissue. Read more
Medtech approvals: FDA releases August 2014 PMAs
October 6, 2014 by Brad Perriello
The U.S. Food & Drug Administration releases a list of pre-market approvals granted in August 2014. Read more
FDA doubtful on new Watchman data from Boston Scientific
October 6, 2014 by Brad Perriello
Preliminary materials from the FDA on the Watchman anti-stroke device from Boston Scientific show that the agency has its doubts about whether to allow the cardiac implant onto the U.S. market.
The FDA’s Circulatory Devices advisory panel is slated to meet Oct. 8 for an unprecedented 3rd review of clinical trial data for the Watchman device. Despite an initial vote recommending approval, the FDA denied in March 2010 issued a “not approvable” letter to Marlborough, Mass.-based Boston Scientific. Read more
