Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Medtronic wins MRI-safe nod from FDA for full suite of cardiac rhythm management devices
Medtronic said today that it won FDA approval for its full suite of MRI-safe cardiac rhythm and heart failure devices and leads for 3- and 1.5-Tesla scans, touting the approval as the 1st of its kind in the U.S.
The regulatory win allows current patients with Fridley, Minn.-based Medtronic’s SureScan MR-conditional pacemakers, implantable cardioverter-defibrillators and cardiac resynchronization therapy-defibrillators and leads to undergo MRI scans anywhere on their body. Read more
4. Titan Medical, Ximedica re-start development program for Sport robot-assisted surgery device
Titan Medical said today that it inked a deal with the principal developer of its Sport robot-assisted surgery platform to re-start the program after its halt earlier this year due to a financial shortfall.
Toronto-based Titan, which ousted longtime CEO John Hargrove earlier this week, put the Sport program on hold in mid-August after Ximedica suspended development until Titan could cover its bills. Adding insult to injury, a planned $16.0 million equity investment from Shanghai JuGu Equity Investment Fund, originally slated to close June 30 and extended to August 15, failed to materialize. Read more
3. Ocular Therapeutix inks $315 deal with Regeneron
Ocular Therapeutix said today that it landed a licensing deal with Regeneron to develop a sustained-release version of Regeneron’s aflibercept (Eylea), a therapy for wet age-related macular degeneration.
The deal will cost Regeneron $10 million up front, and in total could cost the Tarrytown, N.Y.-based biotech $315 million if regulatory and commercialization milestones are met. Read more
2. Histogenics raises $30m for NeoCart regenerative knee treatment
Histogenics said last month that it raised $30 million in a private placement it plans to use for a pivotal trial of its NeoCart regenerative knee treatment.
The Waltham, Mass.-based company said the round, of equity, convertible stock and warrants, was led by new institutional investors and some of its existing backers. The cash infusion should be enough to last the company through the middle of 2018, Histogenics said. Read more
1. Study: Endovascular aneurysm repair shows higher long-term mortality
Endovascular repair of abdominal aortic aneurysms showed a higher mortality rate over the long term compared with open surgical repair, according to a study published yesterday in The Lancet.
The study, “Endovascular versus open repair of abdominal aortic aneurysm in 15-years’ follow-up of the UK endovascular aneurysm repair trial 1,” was based on data from the 1,252-patient Evar trial 1, in which 626 patients were randomly assigned to either EVAR using a stent graft or open surgical repair. The primary endpoint was total and aneurysm-related deaths through mid-2015. Read more
