A Medtronic implant was three times better than an external monitor at detecting new atrial fibrillation in stroke patients, a new study says. The Post-Embolic Rhythm Detection With Implantable Versus External Monitoring (PER DIEM) study pitted Medtronic’s Reveal Linq implantable device, which monitors for AFib over 12 months, against the Spiderflash-T external device made by […]
Sorin Group
LivaNova’s Sorin can’t shake heater-cooler lawsuit
Sorin, which merged last year with Cyberonics to form LivaNova (NSDQ:LIVN), must face a lawsuit brought by cardiac bypass surgery patients alleging that they contracted an infection from the Sorin 3T heater-cooler system used during their procedures. Plaintiffs Edward Baker and Jack Miller alleged that they were exposed to the nontuberculous mycobacterium at a pair of hospitals in Pennsylvania that later […]
FDA warns on risk of heart infection with LivaNova’s Stӧckert 3T heater-cooler
The FDA warned patients and doctors today about the risk of a type of bacterial infection posed by the Stӧckert 3T heater-cooler made by Sorin, known as LivaNova (NSDQ:LIVN) since its merger with Cyberonics last year. Late last year the FDA said it logged 32 reports of patients with infections associated with the devices, with 25 received in 2015. Heater-cooler […]
Japan approves Livanova’s Kora 250 MRI-safe pacemaker
LivaNova (NSDQ:LIVN) said today that it won Japanese approval for its Kora 250 MRI-safe pacemaker line. The Japanese Pharmaceuticals and Medical Devices Agencyapproval for the Kora 250 SR and Kora 250 DR devices covers full-body MRI scans, London-based LivaNova said. The company was formed by the $2.7 billion merger of Sorin Group and Cyberonics last year. “In collaboration with […]
Bioventus taps ex-Medtronic CEO Hawkins for chairman | Personnel Moves
Bioventus said it tapped former Medtronic (NYSE:MDT) and Immucor (NSDQ:BLUD) chief Bill Hawkins to be its new chairman, replacing Dan LeMaitre. Hawkins, who’s slated to appear at the upcoming DeviceTalks event in Raleigh, N.C., had the corner office at Medtronic from 2007 until 2011, when he took the helm at Immucor, where is he lead director. […]
FDA approves LivaNova’s Perceval heart valve
The FDA approved the Perceval sutureless replacement heart valve made by LivaNova (NSDQ:LIVN) (the company formed by the union of Sorin and Cyberonics), the company said today. London-based LivaNova said it plans to begin commercial distribution of the Perceval valve, which is designed to replace the heart’s aortic valve using a self-anchoring frame. “We are excited to […]
FDA warns Sorin on Stockert heater/cooler device
The FDA issued a warning letter late last month to Sorin Group (BIT:SRN) concerning issues with its Stockert Heater Cooler 3T thermal regulator devices. The agency hit the company for marketing the product as something other than a device, outside the FDA’s guidelines. The FDA said the company had responded to its original concerns after an […]
Sorin, Cyberonics name last 2 post-merger board members
LivaNova, the combined company from Sorin Group (BIT:SRN) and Cyberonics (NSDQ:CYBX) merger, announced the last 2 of its remaining board members. The board will contain 9 members, with 4 coming from Sorin, 4 from Cyberonics and 1 elected jointly, the merged companies said. Previously named Sorin designee Massimo Tononi will be replaced by Stefano Gianotti , […]
U.K. regulators OK Sorin-Cyberonics merger
The High Court of England and Wales today approved the $2.7 billion merger of medical giants Cyberonics (NSDQ:CYBX) and Sorin Group (BIT:SRN), now known as LivaNova. The U.K.-approved merger will go into effect October 19, according to the companies. With the approved transaction, each Sorin share will be converted to 0.0472 ordinary shares of $1.52 ( […]
Ex-Medtronic strategy veep Oesterle joins VC shop New Enterprise Associates | Personnel Moves
Venture capital firm New Enterprise Associates said today it picked up ex-Medtronic (NYSE:MDT) executive veep Dr. Stephen Oesterle as a venture partner for the firm. Prior to being an executive veep for the medical giant, Oesterle served as senior veep of medicine and technology, and served as a member of the executive committee for 14 years, […]
Sorin’s Perceval heart valve wins Health Canada nod
Sorin Group (BIT:SRN) said today that it won approval from Health Canada for its Perceval sutureless aortic valve replacement. The valve, which is designed to hold itself in place with a self-anchoring frame, is under review at the FDA now that Sorin has a U.S. investigational device exemption trial under its belt, the company said. “Sorin is […]
