Safety Questions on Paclitaxel Coated Balloons The safety of paclitaxel eluting stents and drug-coated balloons was first brought into question by a meta-analysis published in Journal of the American Heart Association in December 2018. That analysis showed a higher mortality rate at two years post-procedure and prompted the U.S. Food and Drug Administration (FDA) to release its first warning letter on the subject. At that time, the agency asserted that [...]

Peripheral Drug-eluting Balloon Earn FDA Breakthrough Device Designation In addition to the three coronary DCB breakthrough devices mentioned above, two peripheral DCBs also gained breakthrough status in the past year. Orchestra BioMed, in partnership with Terumo, in September 2019 announced breakthrough device designation for the Virtue Sirolimus-Eluting Balloon (SEB) in the treatment of below-the-knee (BTK) peripheral artery disease. The Virtue SEB is a novel, first-in-class drug/device combination product that delivers [...]

Recent FDA Approvals for Drug-eluting Balloons In November 2019, the FDA cleared the Medtronic In.Pact AV DCB for the treatment of failing AV access in patients with end-stage renal disease (ESRD) undergoing dialysis. Over time, vessel restenosis limits the ability to use AV fistulae effectively. In order to restore function, patients often undergo one to three maintenance procedures per year, which can result in significant disruptions to critical hemodialysis care [...]

Use of Drug-coated Balloons in Coronary Arteries to Treat In-stent Restenosis Coronary artery in-stent restenosis (ISR) is observed in about 10 percent of patients who undergo a drug eluting stent (DES) implantation and in more than 30 percent of patients who undergo bare-metal stent (BMS) implantation. Three DEBs for the coronaries have now been granted FDA breakthrough device designation to help expedite the approval process. In July 2020, MedAlliance began enrollment [...]

Recent Developments in Drug-Coated Balloons - Part 1 Several drug-eluting balloons are now designated as breakthrough devices by the FDA The Philips Healthcare Stellarex drug-coated balloon (DCB). It is cleared for use in peripheral vessels and treatment of failing AV access. Drug-coated balloons (DCB), also referred to as drug-eluting balloons (DEB), were created as a way to reduce very high restenosis rates in peripheral vessels. They also have [...]