Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe, the USA, and other markets. It also covers recalls, safety notices, and indication withdrawals. This report (Monday 18 October to Friday 22 November) features FDA approval for IN.PACT AV, a recall for a guidesheath, and FDA Breakthrough Device Designation for Revivent TC. 

FDA approval— IN.PACT AV (Medtronic)
Medtronic has announced FDA approval of its IN.PACT AV drug-coated balloon—a paclitaxel-coated balloon indicated for the treatment of failing arteriovenous access in patients with end-stage renal disease (ESRD) undergoing dialysis. According to a press release, randomised trial results from the IN.PACT AV Access trial show that IN.PACT AV drug-coated balloon can extend the time between reinterventions by maintaining arteriovenous access site patency, therefore, maximising a patient’s uninterrupted access to lifesaving dialysis care.

FDA Breakthrough Device Designation—Wrapsody (Merit)
Merit Medical has been granted Breakthrough Device Designation by the FDA for the Wrapsody endovascular stent graft system. A press release reports that the Wrapsody system is a flexible, self-expanding endoprosthesis for which Merit intends to seek indication for use in haemodialysis patients for the treatment of stenosis within the central veins of the outflow circuit of an arteriovenous fistula up to the superior vena cava.

FDA Breakthrough Device Designation—Revivent TC (BioVentrix)
The FDA has granted Breakthrough Device Designation status for its Revivent TC transcatheter ventricular enhancement system (BioVentrix) for heart failure. A press release reports that the less invasive ventricular enhancement (LIVE) procedures uses Revivent TC System to exclude scar tissue on the left ventricle that has resulted from a myocardial infarction so the healthy portion of the heart can function more efficiently.  It adds that the microanchors are implanted and designed to remodel the heart to a more normal shape and size and reduce wall stress, which has the potential to improve blood flow throughout the body.

FDA 510(k) clearance—Longbow titanium lateral expandable spacer system (Life Spine)
Life Spine has received clearance from the FDA to market the Longbow titanium lateral expandable spacer system. A press release reports that system is available in lengths ranging from 45mm to 60mm, heights from 9mm to 15mm, 0 degrees and 7 degrees lordotic options and widths that expand from 15mm to 27mm anterior to posterior. Additionally, according to the press release, Longbow can be post-packed after expansion in-situ with up to 11cc of graft to fill the implant and features Life Spine’s proprietary Osseo-Loc surface technology.

Recall—Pascal guidesheath (Edwards Lifesciences)
Edwards Lifesciences has issued a recall for the guidesheath (model number: 10000GS and 10000GSCE) that is used in conjunction with the Pascal system for the transcatheter repair of mitral valve regurgitation. According to a letter sent to physicians, there is a potential for damage to the inner liner of the guidesheath because of a manufacturing issue. Based upon current information, the letter reports, the rate of this occurrence is approximately 0.5%, or 1 out of 200 units.