Balloon Specialization Balloon Specialization - Balloon Catheter Coating System from Cheersonic The development direction of medical balloons will be high performance and specialization. For stent delivery and expansion balloons used for luminal shaping, the high performance is to reduce the wall thickness, improve the pressure resistance, and increase the flexibility of the balloon to facilitate its delivery and expansion, but these three properties are mutually restricted. Yes, so [...]

Some New Applications of Medical Balloons Some New Applications of Medical Balloons - Paclitaxel Balloon Coating With the continuous improvement of balloon materials, structure and performance, the application of balloons has become more and more extensive. In addition to the application in PTCA and PTA, balloons are now also used in heat delivery catheters, laser catheters and photoactivation therapy ( PDT), positioning sealed catheters and drug delivery catheters, [...]

Classification of Balloons The performance of the balloon is largely determined by its material, so the classification of the balloon is also the classification of the balloon material. At present, there is no universal criterion for the classification of balloons. There are two types of balloon classification methods recognized by most people in the industry: 1) Balloons are classified into high pressure balloons and low pressure balloons according [...]

Development of Balloon Materials Development of Balloon Materials - Catheter Coatings - Cheersonic So far, the vast majority of medical balloons are made of polymer materials. The original medical balloons were made of soft polyvinyl chloride (PVC). Compared with today's balloons, this kind of balloon has a thicker wall but low pressure resistance. As scientists continue to screen and explore polymer materials, in the early to mid-1980s, balloons [...]

Balloon Catheter Balloon Catheter - Balloon Catheter Coating Systems - CHEERSONIC In 1977, Swedish doctor Gruentzing successfully performed the first percutaneous transluminal coronary angioplasty (PTCA), marking the beginning of interventional medicine. As a young and energetic professional technique, interventional therapy has attracted more and more people's attention for its advantages of small trauma, safety, and reliability. In the past 30 years, especially in the past 10 years, interventional [...]

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 [...]