The FDA is hosting a panel meeting on leadless pacemaker devices, looking to St. Jude Medical (NYSE:STJ) and Medtronic (NYSE:MDT) to join the discussion and make recommendations on acceptable guidelines on the devices. The panel committee will seek recommendations on clinical trial and post approval study design and physician training, and will be asked to make recommendations […]
Cardiac Implants
Medtronic wins expanded PMA for CoreValve
The FDA cleared expanded indications for Medtronic‘s (NYSE:MDT) CoreValve TAVR devices, now cleared for use in patients with end-stage renal disease and those with low-grade, low-flow aortic stenosis. Medtronic won approval from the FDA to modify the CoreValve’s labeling in November which included both its CoreValve and CoreValve Evolut R systems. The changes to the labeling […]
Biotronik wins CE Mark for MRI-safe Ilivia ICD & CRT-Ds
Biotronik said today it won CE Mark approval for its Ilivia ICD and CRT-Ds, which feature the company’s ProMRI and MRI AutoDetect technology to make them compatible with magnetic resonance imaging systems. Biotronik’s MRI AutoDetect feature allows the device to be set to automatically recognize MRIs and switch into MRI mode without having to directly […]
LivaNova wins FDA nod for Crown PRT stented heart valve
LivaNova (NSDQ:LIVN) said today it won FDA premarket approval for its Crown PRT stented aortic heart bioprosthesis for treating aortic valve disorder. The Crown PRT is designed for aortic valve replacements and features optimized hemodynamics and phospholipid reduction treatment designed to improve valve durability, LivaNova said. “Crown PRT is a modern bioprosthesis enabling a simple, safe, […]
Medtronic, St. Jude amongst firms to present data at FDA leadless pacer meeting
Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ) are among medtech firms who have said they will present data on their leadless pacing systems, the Micra and Nanostim, at an FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee. The panel is meeting on Feb. 18 in Gaithersburg, Md. to discuss leadless cardiac pacemaker device technology […]
Greatbatch wins $37.5m patent infringement suit with AVX
Greatbatch (NYSE:GB) said yesterday it won $37.5 million in damages after a jury in the U.S. District Court for the District of Delaware ruled in its favor during a patent infringement case between Greatbatch and AVX. Greatbatch filed the patent infringement complaint in April 2013, alleging that AVX infringed on patents related to filtered feedthrough assemblies […]
Admedus inks exclusive distro deal with Coroneo
Admedus (ASX:AHZ) said today it inked an exclusive distribution agreement with Coroneo to sell its Extra aortic annuloplasty ring ing and other heart valve surgery instruments in Germany and the U.K. Canada-based Coroneo’s Extra aortic ring is designed to repair aortic valves by supporting dystrophic aortic tissue and a downsized dilated valve annulus to restore proper cusp contact. “This […]
AtriCure wins Japanese regulatory nod for AtriClip
AtriCure (NSDQ:ATRC) said today it won approval from the Japanese Ministry of Health, Labor and Welfare for its AtriClip line of products designed for the occlusion of the left atrial appendage. The approval was achieved through the aid of the company’s Japanese distributor Century Medical Inc, the West Chester, Ohio-based company said. “We are excited to […]
J&J joins Edwards in $28m Series B for arterial shunt dev V-Wave
Johnson & Johnson (NYSE:JNJ) joined previous investor Edwards Lifesciences (NYSE:EW) in a $28 million Series B round to support heart failure treating interarterial shunt maker V-Wave, according to a press release posted yesterday. Other groups joining the round included newly-invested TriVentures, Pura Vida Investments and BioStar Ventures, with returning investors Pontifax and the BRM group. “With the […]
Endotronix pulls in $3.5m for wireless heart monitor
Endotronix raised $3 million and is looking to bring in another $540,000 in a new round of debt financing, according to an SEC filing posted last week. Woodridge, Ill.-based Endotronix develops wireless cardiac monitors, including a ‘tiny pressure sensor’ designed to be implanted in a patient’s pulmonary artery during a catheterization procedure, to wirelessly return PA […]
FDA clears Biotronik’s full-body MRI-safe Iperia ICDs
Biotronik said last week it won FDA premarket approval for its Iperia family of magnetic resonance imaging-compatible implantable cardioverter defibrillators. The approval includes Biotronik’s Iperia DR-T DF-1 and DF4 configurations, the Iperia DX and Iperia ProMRI DX, the company said. “Our goal is to integrate ProMRI technology across our entire line of implantable systems, and […]