Global Approvals Snapshot August 2019
An overview of the global medical device approvals in September, as captured by Medtech Insight's Approvals Tracker. Approvals of several major cardiovascular devices highlighted what was otherwise a slow month for medical device approvals.
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The PMA approval is based on the results of the BeAT HF trial, which showed that baroflex activation therapy with Barostim Neo safely improves quality-of-life scores and exercise capacity in patients with heart failure and reduced ejection fraction.
As expected, the US FDA has expanded the approved indication for four transcatheter aortic valves – Edwards Lifescience’s Sapien 3 and Sapien 3 Ultra, and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – to include patients at low risk for complications during surgery.
Medtronic will stop producing ventilators and combine the rest of its patient monitoring and respiratory interventions business into a new business called acute care and monitoring. The company had previously announced plans to divest all of the patient monitoring and respiratory intervention business.