Symetis has announced its Acurate TA and Acurate TF TAVI systems have been successfully implanted in patients in Japan as part of a feasibility study to secure the Pharmaceutical and Device Agency's (PMDA) pre-market approval. Based on a ...
Tags: Symetis, TAVI Systems
Sorin, a medical device firm, has entered into deal to manufacture certain components of Boston Scientific's Lotus Aortic Valve System. Lotus Aortic Valve System is Boston Scientific's second-generation transcatheter aortic valve ...
Tags: Aortic Valve System, Sorin Inks
Sorin Group has received an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to commence a clinical study of its PERCEVAL S sutureless aortic tissue valve. The bioprosthetic valve is designed ...
US-based medical technology company Medtronic has secured US marketing rights for its Affinity Fusion oxygenation system following the regulatory approval from the US Food and Drug Administration (FDA). The CE-marked system, which serves ...
Tags: FDA, Fusion Oxygenation System
CellAegis Devices has obtained Health Canada's marketing authorization for its proprietary, automated, noninvasive device autoRIC device for remote ischemic conditioning (RIC). The Medical Device Class III license, granted by Health ...
US-based CorMatrix Cardiovascular has completed trial on its ECM technology that helps in closing the pericardium of patients undergoing postoperative coronary artery bypass grafting (CABG) and said the trial results confirm its safe use. ...
Tags: CorMatrix Cardiovascular, ECM technology, pericardium, CABG
BioVentrix has launched a myocardial anchoring system for patients with ischemic cardiomyopathy. The new technology, Revivent, is designed for use in less invasive ventricular enhancement (LIVE) procedures to improve the function of ...
Sorin Group, a manufacturer of medical technologies for cardiac surgery, has purchased Neurotech to expand its market of neuromodulation therapies for treating heart failure. Neurotech's commercial products include implantable medical ...
Tags: cardiac surgery, medical technology, expansion, medical device
The AtriCure has obtained the US Food and Drug Administration (FDA) clearance to commence three-year Ablate post approval study (PAS), designed for the surgical correction of atrial fibrillation. The 350 patient study is designed to ...
Tags: AtriCure, FDA clearance, post approval study, PAS, Synergy ablation system
Sorin Group has announced the US launch of a Mitroflow Valsalva Conduit graft, designed for use in combination with a Mitroflow pericardial aortic valve. The Conduit graft enables surgeons to replace simultaneously the ascending aorta and ...
Tags: Sorin, launch, Conduit graft, combination, Mitroflow graft
Abbott has signed an agreement to acquire all global rights to develop and commercialize AP214 from Action Pharma. AP214 is a hormone analogue which is being developed to prevent acute kidney injury associated with major cardiac surgery ...
Tags: AP214, Abbott, Action Pharma
Micro Interventional Devices has initiated first-in-man Sutureless Transapical Access and Closure study (STASIS) trial to demonstrate the efficacy of its transapical access device in providing hemostatic access to the left ventricle during ...
Tags: Micro Interventional Devices, man Sutureless, cardiac procedures
Sphere Medical has presented positive results of its in-vitro diagnostic medical device designed for measuring intravenous anaesthetic propofol at the point of care. The device, Pelorus 1500, provides real time measurements of propofol ...
Tags: Sphere Medical, medical device