GlySure said today that it won CE Mark approval in the European Union for its continuous intravascular glucose monitoring system. The CIGMS device was cleared to monitor blood glucose among adult cardiac surgery patients in intensive care units, Abingdon, England-based GlySure said. In a clinical trial, the device met the primary safety and efficacy endpoints […]
Clinical Trials
Sanuwave updates on PMA trial for Dermapace
Sanuwave Health (OTC:SNWV) said yesterday it met with the FDA to discuss the progress of a pre-market approval trial of its Dermapace diabetic foot ulcer treatment. The 130-patient study completed enrollment in November last year and each patient has completed a full-24-week follow-up, the Alpharetta, Ga.-based company said. Sanuwave said it is completing an audit of the clinical documentation of […]
St. Jude Medical launches OCT stenting trial
St. Jude Medical (NYSE:STJ) today said it’s launching the 1st trial comparing optical coherence tomography device with intravascular ultrasound or angiography during stenting procedures. St. Paul, Minn.-based St. Jude said the 420-patient Ilumien III trial will compare treatment with its Optis Integrated and Ilumien Optis percutaneous coronary intervention optimization systems in treating patients with stable or unstable angina, silent ischemia or […]
UPDATE: Medical societies update stroke guidelines
A bevy of cardiac medical societies updated their guidelines for stroke treatment yesterday to take into account new devices and technology, including left atrial appendage occlusion devices, stent retrievers and thrombectomy devices. The American College of Cardiology, Heart Rhythm Society and Society for Cardiovascular Angiography and Interventions have updated their guidelines to include the benefits of left […]
Ethicon takes on ‘diabesity’ with $3m research program
Johnson & Johnson’s(NYSE:JNJ) Ethicon subsidiary said today that it’s dropping $3.2 million on a research program on the effects of early surgical intervention on obesity and Type II diabetes. Cincinnati-based Ethicon said its “Time to Act on Obesity” program involves more than 20 clinical trials enrolling some 2,000 patients and investigator-initiated studies in 5 countries. “We […]
AHA/ASA updates stroke treatment guidelines
The American Heart Association/American Stroke Association said today that it updated its treatment guidelines for patients suffering from ischemic stroke to include endovascular treatments. The decision supports the use of stent retrieval, and other thrombectomy devices, used to remove clots in patients who have obstructions in the large arteries supplying blood to the brain according […]
Bard touts publication of Lutonix study in NEJM
C.R. Bard (NYSE:BCR) said last Thursday that a 2-year study of its Lutonix drug-coated balloon catheter was published in The New England Journal of Medicine. The 2-year Levant 2 study data showed non-inferiority of the device and a trend towards superiority, compared to standard percutaneous transluminal angioplasty, in the treatment of peripheral artery disease, the company said. “We want to thank […]
Kips Bay Medical pulls the plug
Kips Bay Medical (OTC:KIPS) said last week it will be liquidating the company after terminating the Emesh I clinical feasibility trial of its eSVS mesh based on poor 6-month results. The company’s board of directors unanimously approved a plan to dissolve the company and return any remaining cash to its stockholders, Minneapolis, Minn.-based Kips Bay said. Kips […]
SentreHeart wins FDA nod for Lariat trial
SentreHeart said yesterday it won FDA investigational device exemption approval to begin enrolling subjects in a clinical trial of its Lariat device. The Amaze trial will evaluate the use of the Lariat for the ligation of the left atrial appendage as an adjunctive treatment to ablation in patients with persistent atrial fibrillation, the company said. “The […]
Cardiac Dimensions launches clinical trial for Carillon mitral valve device
Cardiac Dimensions today said it launched a clinical trial of its Carillon device, which is designed to treat functional mitral valve regurgitation. The 120-patient Reduce FMR study is a prospective, double-blind, randomized multi-center trial, Kirkland, Wash.-based Cardiac Dimensions said. Patients are slated to be randomized on a 3:1 basis to receive the Carillon device and optimal drug […]
AxoGen enrolls first subject in nerve graft study
AxoGen Inc. (NSDQ:AXGN) said yesterday that it enrolled the 1st subject in a clinical trial of its Avance nerve graft. The multicenter, prospective randomized Recon study will compare the Avance graft to nerve tubes currently used for bridging peripheral nerve tissue gaps, the Florida-based regenerative medicine company said. The data from the Recon trial will […]
