UPDATED Feb. 10, 2015, with comments from trial investigators and Silk Road Medical.
The FDA today said it granted 510(k) clearance to the anti-stroke Enroute device made by Silk Road Medical.
FDA OKs Silk Road Medical’s anti-stroke Enroute device
Stroke
Mr. Clean: Device makers jump on positive thrombectomy results in stroke trial
Survey: Stroke still a mystery to many
UPDATE: 3rd FDA panel vote barely favors Boston Scientific’s Watchman anti-stroke device
Press Release: REVIVE SE thrombectomy device approved for ischemic stroke patients in China, South Korea and Taiwan
DePuy’s Codman Neuro expands in Asia Pacific with new approvals
Massachusetts-based Codman Neuro is preparing to take Asia Pacific by storm with new regulatory wins in China, South Korea and Taiwan for the company’s Revive SE thrombectomy device.
Study: Afib doubles stroke risk after surgery
Results from a new study suggest that atrial fibrillation (AF) may pose a significant threat to patients undergoing surgery, especially those having non-cardiac procedures.
In an analysis of more than 1.7 million patients, researchers found that perioperative AF was associated with twice the risk of stroke in patients who had non-cardiac surgery. Patients who underwent a cardiac procedure saw a 30% increase in their stroke risk.
Israel-based Keystone Heart raises $14M for cerebral protection
Israeli device maker Keystone Heart raised $14 million in a Series B funding round in support of its TriGaurd implant, designed to help protect the brain during transcatheter valve replacement procedures.
HRS2014: Devices combat drugs for treatment of AF stroke-risk patients
New clinical data continues to suggest that left atrial appendage occlusion devices may pose an improvement over warfarin drug regimens for treating patients at increased risk of stroke, researchers reported today.
Study: AliveCor’s mobile ECG helps discover hidden stroke risk
Smartphone-based community ECG readings may help save lives as well as healthcare dollars, according to a study unveiled by mobile health company AliveCor.
