Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.
3. Senseonics sets terms for $64m offering
Senseonics set the terms today on a public stock offering that could fetch nearly $64 million, as the implantable glucose monitor maker looks to move to the New York Stock Exchange.
Germantown, Md.-based Senseonics said it plans to float 18.2 million shares at $3.10 to $3.50 apiece; SENH shares traded at $3.30 each March 4, their last day of trading (only about 100,000 shares have changed hands since the stock’s debut Dec. 22, 2015). That works out to a range of $56.4 million to $63.7 million. Read more
2. FDA approves trial for Inari Medical’s clot-busting FlowTriever
Inari Medical said today that it won an investigational device exemption from the FDA for a clinical trial of its FlowTriever device, which is designed to retrieve pulmonary embolisms.
Irvine, Calif.-based Inari said it expects to begin enrollment in the 150-patient Flare trial in the coming weeks. The primary safety endpoint is major adverse events within 48 hours, defined as device-related death, major bleeding, and treatment-related events. The efficacy endpoint is reduction in right ventricle/left ventricle ration from baseline to 48 hours. Read more
1. J&J’s Ethicon touts Evarrest in study of aortic repair
Johnson & Johnson subsidiary Ethicon is touting a Phase III clinical study of its Evarrest fibrin sealant patch in surgeries to repair the aorta, saying the patch handily beat Baxter’s competing TachoSil product.
Ethicon said the 156-patient Evarrest CV trial showed that hemostasis was achieved within 3 minutes and maintained throughout the surgery for 75% of the Evarrest cohort, compared with 45% for the TachoSil arm. The study tracked aortic graft anastomotic suture line bleeding at 3 minutes, 6 minutes, 10 minutes and until closure. Ethicon said Evarrest also met a secondary endpoint in the trial, hemostasis at 6 and 10 minutes, at 77.6% and 84.2%, respectively, compared with 56.3% and 70% for patients treated with TachoSil. There were no major safety concerns, the company said. Read more
The post MassDevice.com +3 | The top 3 medtech stories for March 8, 2016 appeared first on MassDevice.
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