Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe and the USA. It also covers recalls, safety notices, and indication withdrawals. This report covers from Monday 19 August to Friday 23 August. 

FDA Class I recall—delivery system of Sapien 3 Ultra
The FDA has issued a Class I recall—which it describes as “the most serious type of recall”—for the delivery system of the Sapien 3 Ultra transcatheter aortic valve implantation (TAVI) system. The recall follows Edwards Lifesciences receiving reports of burst balloons during implantation procedures, and it comes just under a week after the FDA approved the Sapien 3 Ultra system (alongside Sapien 3 and Medtronic’s Evolut R and Evolut PRO devices) for the management of aortic stenosis in low-risk patients.

FDA Breakthrough Device Designation—PiCSO impulse system (Miracor Medical)
Miracor Medical has been granted Breakthrough Device Designation by the FDA for its PiCSO Impulse System for treatment of ST-segment elevation myocardial infarction (STEMI) patients. The PiCSO impulse system is designed to clear the coronary microcirculation by intermittently occluding the coronary sinus outflow resulting in improved perfusion of the infarcted area of the heart. A press release reports that this mechanism of action is unique and very differentiated.

If  your company would like to be included in this roundup, please send details of FDA/CE mark approvals etc. [email protected].