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. BoneSupport launches trial of antibiotic-eluting bone graft
BoneSupport said today that the 1st patient has been enrolled in the pivotal investigational device exemption trial for its injectable antibiotic-eluting bone graft substitute.
The company’s Fortify trial plans to evaluate Cerament G’s ability to improve the traditional management of patients with open factures of the tibial diaphysis. The trial is slated to enroll up to 230 patients and the primary endpoints are the absence of deep infection at the fracture site and the lack of secondary procedures designed to encourage fracture union. Read more
4. EuroPCR Roundup: Bioresorbable stents show promise, but metallic drug-eluting stents remain standard
Abbott‘s bioresorbable scaffold has been plagued with a myriad of troubling data, including a study that showed that the device is associated with an increase in thrombosis and target lesion failure. In April, Abbott pulled the stent from European markets.
In response to widespread criticism of the technology, the EuroPCR team released a statement this week defending bioresorbable stents as “an important option to optimise outcomes in patients whose needs are not adequately met with current devices.” Read more
3. BTG touts Ekos data from pulmonary embolism trial
BTG touted data today from the Optalyse PE trial showing that pulmonary embolism can be treated effectively with Ekos over a shorter period and with smaller doses of thrombolytic drugs compared to the current standard.
The 101-patient trial randomized participants to receive therapeutic anticoagulation and Ekos acoustic pulse thrombolysis therapy at different doses for different lengths of time. The 1st group received 4 milligrams per catheter of tissue plasminogen activator over 2 hours, while the 2nd cohort received the same dose over 4 hours. The 3rd group was treated with 6 milligrams per catheter over 6 hours and the 4th group received 12 milligrams per catheter over 6 hours. Read more
2. Zimmer Biomet warns on isocentric movement issues in Rosa platforms
Zimmer Biomet today issued a voluntary medical device field action for its Rosa Brain, Rosa Spine and Rosa One surgical robotic platforms over movement issues with the systems’ robotic arms.
The company said that a situation can occur where the robot arm’s position is automatically sent to the trajectory input due to an imperfect mathematical model that could prevent the arm from reaching its desired position. Read more
1. QT Vascular shops coronary assets
QT Vascular said today that it’s in discussions to sell its coronary assets, apart from the Chocolate PTA device it’s already looking to deal to Medtronic.
Earlier this month, QT Vascular said Medtronic agreed to pay $28 million for an option on the Chocolate PTA non-drug-coated balloon for treating peripheral vascular disease, after inking a 5-year deal in February calling for Medtronic to distribute the Chocolate PTA device. Read more
