LivaNova (NSDQ:LIVN) said today that it agreed to a deal for ImThera Medical and its implantable sleep apnea treatment worth $225 million. San Diego-based ImThera’s flagship product is the Aura6000, an implanted hypoglossal nerve stimulator that won FDA investigational device exemption in November 2014 for a pivotal trial. The device uses a pair of implanted components, one near the […]
LivaNova
LivaNova to deal CRM biz to MicroPort for $190m
LivaNova (NSDQ:LIVN) said today that it inked a deal to sell its cardiac rhythm management business to China’s MicroPort Scientific (HK:00853) for $190 million in cash. The companies, which are already partners in a CRM join venture in the People’s Republic, said the sale for LivaNova’s 900-worker CRM business is slated to close during the second quarter […]
LivaNova swings to Q3 black
LivaNova (NSDQ:LIVN) today swung to profitability during the third quarter and raised its earnings outlook for the rest of 2017, after handily beating the consensus forecast on Wall Street. The London-based medical device company reported profits of $27.8 million, or 57¢ per share, on sales of $309.7 million for the three months ended Sept. 30, compared […]
LivaNova wins FDA nod for SenTiva VNS epilepsy treatment
LivaNova (NSDQ:LIVN) said this week it won FDA approval for its vagus nerve stimulation therapy system consisting of its SenTiva implantable generator and a next-gen VNS therapy programming system for treating patients with drug-resistant epilepsy. The London-based company touted the SenTiva generator as the smallest and lightest responsive therapy for epilepsy on the market. The system […]
LivaNova, Microport win approval for Rega pacemakers in China
LivaNova (NSDQ:LIVN) and MicroPort Scientific (HKG:0853) said today that the group’s joint venture, MicroPort Sorin Cardiac Rhythm Management Co., won approval for its family of Rega pacemakers in China. The Rega devices are the first domestically manufactured pacemakers that meet international standards in China, the companies touted. The pacemakers are the smallest on the Chinese cardiac […]
LivaNova nabs 510(k) clearance for Optiflow Arterial cannulae
LivaNova (NSDQ:LIVN) said today that it won 510(k) clearance from the FDA for its family of Optiflow Arterial cannulae. The London-based company touted its aortic arch cannula as providing improved hydrodynamics and boasting a novel dispersive tip that boosts blood flow characteristics and reduces wall shear stress profiles. Optiflow Arterial cannulae have a “basket tip with […]
LivaNova mulls sale for CRM biz
LivaNova (NSDQ:LIVN) said today that it’s considering a sale for its cardiac rhythm management business, tapping Barclays to shop the $250 million operation to potential buyers. “As part of our ongoing efforts to position LivaNova for long-term success, we are sharpening our focus on the company’s areas of strength and market leadership. To that end, we […]
LivaNova heater-cooler implicated in infections in 12 pediatric heart surgery patients
A dozen children who underwent cardiac procedures at Children’s Hospital New Orleans earlier this year have been infected with myobacterium previously linked to LivaNova’s (NSDQ:LIVN) 3T Heater-Cooler systems, according to a STAT News report. A total of 55 children had heart surgery between May and July at the facilities, with 7 of the 12 patients […]
LivaNova shares rise on Q2 beat
Shares in LivaNova (NSDQ:LIVN) rose today after the medical device maker beat expectations on Wall Street with its 2nd quarter earnings results. The London-based company posted profits of $47.5 million, or 98¢ per share, on sales of $321.4 million for the 3 months ended June 30, seeing massive bottom-line growth of 427.8% while sales grew a […]
UPDATE: CMS passes NTAP reimbursement for LivaNova’s Perceval, Edwards Intuity aortic valves
Updated to include that the CMS NTAP also covered Edwards Lifescience’s Intuity suturless aortic valve The Centers for Medicare and Medicaid Services today released its Final Rule for FY2018 Medicare Inpatient Payment and Policy, granting New Technology Add-On Payment reimbursement for rapid deployment valves, including LivaNova‘s (NSDQ:LIVN) Perceval and Edwards Lifesciences‘s (NYSE:EW) Intuity aortic valves. London-based LivaNova said […]
LivaNova wins MRI-safe CE Mark for VNS Therapy systems
LivaNova (NSDQ:LIVN) said today it won expanded CE Mark approval in the European Union for its Vagus Nerve Stimulation Therapy systems, now labeled as safe for 1.5T and 3T magnetic resonance imaging scans. The labeling change for the London-based medical device maker includes its AspireHC and AspireSR devices, allowing patients with existing devices to safely have MRI […]