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 […]
LivaNova touts CMS reconsideration of VNS therapy treatment for TRD
LivaNova (NSDQ:LIVN) today announced that the US Centers for Medicare & Medicaid Services are reconsidering a National Coverage Determination covering the use of vagus nerve stimulation technology for treating treatment-resistant depression. CMS last considered covering VNS treatment for TRD in 2007, but declined the coverage due to “insufficient evidence.” “In 1999, CMS established coverage of vagus […]
8 companies commercializing transcatheter mitral valve replacements
Transcatheter mitral valve replacement is a new frontier in the cardio device field, with big legacy medical device companies including Edwards Lifesciences, Medtronic and Abbott spending hundreds of millions of dollars on companies in the space. Much different from transcatheter aortic valve replacement (TAVR), transcatheter mitral valve replacement (TMVR) has been mostly experimental. TMVR is used […]
LivaNova shares down despite Street-beating Q1
Shares in LivaNova (NSDQ:LIVN) fell today despite the medical device maker beating the Street on earnings per share and sales with its first quarter earnings results. The London-based company posted profits of $13.3 million for the three months ended March 31, seeing 17.7% growth on the bottom-line while sales grew by 10.4% compared with the same […]
LivaNova closes $190 CRM sale to MicroPort
LivaNova (NSDQ:LIVN) said today that it closed the $190 million sale of its cardiac rhythm management business to China’s MicroPort Scientific (HK:00853). The companies are already partners in a CRM join venture in the People’s Republic. LivaNova, formed by the $2.7 billion merger of Italy’s Sorin and Cyberonics in October 2015, said in September that it was putting the CRM business on the auction […]
LivaNova wins CE Mark for SenTiva VNS epilepsy treatment
LivaNova (NSDQ:LIVN) said today it won CE Mark in the European Union for its Vagus Nerve Stimulation Therapy system, now indicated for treating patients with drug-resistant epilepsy. The VNS Therapy system is composed of the London-based company’s SenTiva implantable generator and a next-gen VNS therapy programming system. LivaNova touted the SenTiva generator as the smallest and […]
LivaNova closes $250m TandemLife buy
LivaNova (NSDQ:LIVN) said today it closed its $250 million acquisition of cardiopulmonary temporary support solutions developer TandemLife . In the deal, London-based LivaNova said it paid $200 million up front with an additional $50 million to be paid based on specific regulatory milestones. The company said it expects the acquisition to be moderately accretive this year. […]
LivaNova wins expanded CE Mark labeling for Bicarbon aortic valve
LivaNova (NSDQ:LIVN) said today it won expanded CE Mark labeling for its Bicarbon aortic heart valves, now cleared for use with low-dose anticoagulant therapy. The new approval clears low risk patients who’ve received a Bicarbon aortic valve implant to be targeted using a lower international normalized ratio measurement of blood coagulability, allowing for a lower-range level […]
LivaNova launches Microburst VNS drug-resistant epilepsy trial
LivaNova (NSDQ:LIVN) said today it launched a new feasibility trial of its Microburst Vagus Nerve Stimulation therapy system exploring its safety and effectiveness in treating patients with drug-resistant epilepsy. The London-based company said that Dr. Rebecca O’Dwyer of Chicago’s Rush University Medical Center has enrolled the first patient in the trial, which aims to enroll a […]
LivaNova launches Chinese Perceval trial
LivaNova (NSDQ:LIVN) said today it launched a new trial of its Perceval sutureless aortic valve implant in China as it pursues Chinese Registration of the device. The 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 the Perceval valve […]
LivaNova finalizes details in $190m CRM sale to MicroPort
LivaNova (NSDQ:LIVN) said today it finalized the details in a deal to sell its cardiac rhythm management business to China’s MicroPort Scientific (HK:00853) in a deal worth $190 million. The companies, which are already partners in a CRM joint venture in the People’s Republic, originally announced the deal last November. London-based LivaNova said that its announcement follows “successful […]
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