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 […]
LivaNova wins Japanese reimbursement for Perceval aortic valve
LivaNova (NSDQ:LIVN) said today that it won national reimbursement through Japan’s Ministry of Health, Labour and Welfare for its Perceval sutureless aortic heart valve intended to treat aortic valve disease. The London-based company said that the elastic Perceval valve’s sutureless design allows it to achieve optimal effective orifice area for improved hemodynamics. The company said that […]
LivaNova touts CMS trial clearance for vagus nerve depression treatment system
LivaNova (NSDQ:LIVN) said on Wednesday that the U.S. Centers for Medicare & Medicaid Services finalized a National Coverage Decision for LivaNova’s Vagus Nerve Stimulation Therapy for treating treatment-resistant depression. The London-based company said that the modified NCD will enable Medicare coverage for VNS therapy through the Coverage with Evidence Development framework when offered through a CMS-approved, […]
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