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, […]
Edwards Lifesciences settlement with Boston Scientific lets Neovasc off the hook
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 […]
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