Last week’s legal win for Boston Scientific (NYSE:BSX) in its years-long patent battle with Edwards Lifesciences (NYSE:EW) was also a win for Neovasc (NSDQ:NVCN), that company said today. As part of a settlement deal worked out between Irvine, Calif.-based Edwards and Marlborough, Mass.-based Boston Scientific, the Federal Court of Canada dismissed a lawsuit brought by Edwards against Boston, […]
CMS wants clinical trial for LivaNova’s neurostim depression device
The U.S. Centers for Medicare & Medicaid Services has proposed the launch of a clinical trial testing out LivaNova‘s (NSDQ:LIVN) Vagus Nerve Stimulation therapy system intended to treat Treatment-Resistant Depression as it looks to adjust its National Coverage Determination for the device. The London-based medtech company said that with CMS’ proposal to change the NCD for […]
LivaNova takes a hit on Q3 sales miss, despite raised outlook
LivaNova (NSDQ:LIVN) shares came under pressure today after the medical device maker put up sales and earnings numbers that fell shy of expectations as it swung to third-quarter red ink, despite its boosted top-line outlook for 2018. LivaNova posted losses of -$7.2 million, or -15¢ per share, on sales of $272.1 million for the three months […]
LivaNova updates on 3T Heater-Cooler infection prevention corrections
LivaNova (NSDQ:LIVN) this week updated customers on efforts to correct issues with its 3T Heater-Cooler related to patient infections, providing instructions to monitor hydrogen peroxide concentration and information on a design upgrade. In a medical device correction letter dated October 18, the company sent instructions for monitoring hydrogen peroxide concentration to limit microbial growth, enhancing previous […]
LivaNova gets in on EEG maker Ceribell’s $35m Series B
LivaNova (NSDQ:LIVN) has joined a $35 million Series B round for electroencephalogram device maker Ceribell. Mountain View, Calif.-based Ceribell is developing a Rapid Response EEG system, which consists of a disposable headband and mobile recorder and is intended for the rapid diagnosis of patients with suspicion of seizure. Data is transmitted through a HIPAA compliant cloud […]
LivaNova launches pivotal study for Vitaria heart failure device
LivaNova (NSDQ:LIVN) said today that it launched a pivotal study of its Vitaria neuromodulation implant for treating heart failure. The 800-patient Anthem-HFrEF study’s first subject was implanted with the Vitaria vagus nerve stimulation device at St. Luke’s Hospital in Cedar Rapids, Iowa, the London-based company said. Patients enrolled in the trial are slated to be randomized on […]
LivaNova launches global study of epilepsy treatment
The first patient with drug-resistant epilepsy has received LivaNova’s (NASDAQ:LIVN) vagus nerve stimulation (VNS) therapy system, kicking off enrollment of a global registry to evaluate it, the company said. Drug-resistant epilepsy (DRE) affects nearly one in three people with epilepsy, according to an article in the New England Journal of Medicine. The LivaNova study will […]
LivaNova touts completion of 1st-in-man transseptal Caisson TMVR feasibility study
LivaNova (NSDQ:LIVN) said today it concluded the Prelude first-in-human feasibility study exploring the transseptal use of its Caisson transcatheter mitral valve replacement system designed to treat mitral valve regurgitation. In the study, investigators explored the use of the Caisson TMVR system through a transseptal approach, which the London-based company claims is a less-invasive approach which uses […]
LivaNova beats Q2 expectations
LivaNova (NSDQ:LIVN) handily topped the consensus forecast for its second-quarter results despite a huge bottom-line slide. Formed by the $2.7 billion merger of Italy’s Sorin and Cyberonics in October 2015, in April the company closed the $190 million sale of its cardiac rhythm management business to China’s MicroPort Scientific (HK:00853) and paid $250 million to acquire TandemLife and its cardiopulmonary temporary support […]
LivaNova wins FDA nod for Memo 4D mitral annuloplasty ring
LivaNova (NSDQ:LIVN) said today it won FDA 510(k) clearance for its Memo 4D semi-rigid mitral annuloplasty ring, and said that the device has been used in its first commercial procedure. The Memo 4D mitral annuloplasty ring is a next-generation device designed for treating patients with mitral regurgitation, and is available in sizes from 24 mm to […]
LivaNova wins Japanese nod for Perceval aortic valve
LivaNova (NSDQ:LIVN) said today it won approval from Japan’s Ministry of Health, Labour and Welfare for its Perceval sutureless aortic heart valve designed to treat aortic valve disease. The London-based company claims that the lack of suturing allows the super-elastic Perceval valve to achieve optimal effective orifice area, resulting in “excellent hemodynamics.” LivaNova said procedures utilizing […]
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