- In July 2024, Teleflex Incorporated announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Ringer Perfusion Balloon Catheter (PBC), the only commercially available Percutaneous Transluminal Coronary Angioplasty (PTCA) perfusion balloon. The Ringer™ PBC is a rapid-exchange catheter, compatible with 0.014” guidewires, featuring a distinctive helical balloon at its working end. When inflated, the balloon takes the shape of a hollow cylinder with a large central perfusion lumen
- In March 2024, Boston Scientific Corporation announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its AGENT Drug-Coated Balloon (DCB), designed to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR refers to the narrowing or blockage of a stented vessel due to plaque buildup or scar tissue
- In August 2023, Shanghai MicroPort Medical (Group) Co., Ltd. announced that its Firefighter NC Pro PTCA Balloon Catheter (Firefighter NC Pro) had received market authorization from the U.S. Food and Drug Administration (FDA). The Firefighter NC Pro is designed to improve myocardial perfusion and is intended for balloon dilation of narrowed coronary arteries or coronary artery bypass grafts. It is also suitable for post-dilation following stent implantation. The Firefighter NC Pro features a three-layer composite material design for the balloon, with a maximum rated burst pressure of up to 22 atmospheres
- In June 2023, Cook Medical announced the addition of new size options and locations for its Advance Serenity hydrophilic percutaneous transluminal angioplasty balloon catheter product line. This device, used by interventionalists in both below- and above-the-knee procedures, helps treat patients with peripheral artery disease (PAD). The catheter is produced by Surmodics and distributed by Cook Medical
- In June 2022, Royal Philips revealed the latest findings from the Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) clinical trial. The results showed that Philips' Tack (4F) endovascular system, the first and only device of its kind approved by the U.S. Food and Drug Administration (FDA), offers a lasting treatment effect and a positive impact on the quality of life for patients with critical limb ischemia (CLI), a severe form of peripheral arterial disease (PAD), over a three-year clinical follow-up period
