LivaNova (NSDQ:LIVN) said today that it is ending its Caisson Interventional transcatheter mitral valve replacement (TMVR) program and plans to restructure its heart valve business to improve profitability. The company’s heart valve business represented nearly $130 million in revenue during fiscal 2018 and saw its revenue numbers decline over the last five years, both with biological […]
LivaNova slumps on Q3 revenues miss
LivaNova (NSDQ:LIVN) shares slumped in early trading today after the medical device company reported lower-than-expected third-quarter revenues, despite a swing to black ink and a health beat on earnings. London-based LivaNova posted profits of $32.1 million, or 66¢ per share, on sales of $268.6 million for the three months ended Sept. 30. That compares with losses […]
LivaNova recalls VNS generators
LivaNova (NSDQ:LIVN) is recalling some of its Model 1000 SenTiva vagus nerve stimulation therapy (VNS) generators, which may reset themselves during therapy. A component supplied by an outside company produces an error that causes the generator to reset and fail to deliver the intended VNS therapy, according to London-based LivaNova. Resets may occur during routine […]
LivaNova launches vagus nerve stim depression study
LivaNova (NSDQ:LIVN) said last week that it enrolled its first patient in a study of vagus nerve stimulation therapy for treatment-resistant depression. The Recover study is designed to determine whether active VNS therapy is a superior option compared to a no-stimulation control in producing a reduction in baseline symptom severity of depression. LivaNova plans to enroll […]
LivaNova wins Medicare nod for nerve stimulation trial
Medicare has approved a LivaNova (NSDQ:LIVN) study of vagus nerve stimulation (VNS) to treat depression, the company said today. The Centers for Medicare and Medicaid Services accepted the London-based company’s protocol for a clinical trial to study the safety and effectiveness of adding VNS to traditional depression treatment in patients with treatment-resistant depression. Approval of […]
LivaNova slides on Q1 misses, slashed outlook
LivaNova (NSDQ:LIVN) shares took a hit today after the medical device maker posted first-quarter results that missed the consensus forecast and slashed its earnings outlook for the rest of the year. London-based LivaNova reported losses of -$14.8 million, or -31¢ per share, on sales of $250.8 million for the three months ended March 31. That compares […]
LivaNova shares plummet on prelim Q1 miss
LivaNova (NSDQ:LIVN) shares have plunged over 25% so far today after the medical device maker posted preliminary sales numbers for its first quarter that fell below expectations on Wall Street. The London-based company said that it expects to post sales of $250.5 million for the quarter, well below the Wall Street expectations of $264.6 million. The […]
LivaNova to settle majority of U.S. 3T Heater-Cooler cases
LivaNova (NSDQ:LIVN) said that it inked a deal to settle approximately 75% of litigations it faces in the U.S. related to its 3T Heater-Cooler device, which has been implicated in a number of unexpected severe patient infections, expecting to pay up to $225 million to settle the claims. In June 2016, the FDA warned patients […]
LivaNova’s CMS vagus nerve depression device trial must include sham arm
A new U.S. Centers for Medicare & Medicaid Services trial of LivaNova‘s (NSDQ:LIVN) Vagus Nerve Stimulation Therapy system intended to treat treatment-resistant depression will require a sham-control arm, doubling the subject population LivaNova originally expected. The trial, which the London-based company won clearance from CMS for last month, will allow coverage for the VNS devices […]
Nevro taps ex-Thoratec CEO Grossman | Personnel Moves, March 20, 2019
Nevro Corp. (NYSE:NVRO) said yesterday that it named former Thoratec CEO Keith Grossman to replace president & CEO Rami Elghandour after striking a deal with one of its investors, Broadfin Capital. Grossman re-joined Thoratec after taking over at Conceptus in December 2011 and leading it to a $1.1 billion sale to Bayer in June 2013 (he’d […]
LivaNova shares dip despite Q4, 2018 earnings beat
Shares in LivaNova (NSDQ:LIVN) fell today despite the medical device maker posting fourth quarter and full year 2018 earnings that topped expectations on Wall Street. The London-based company posted losses of $210.6 million, or $4.34 per share, on sales of $297 million for the three months ended December 31, seeing losses grow 88.5% while sales grew […]
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