Biosensors’ Rise SC Balloon Evaluated in First-in-Human Trial

February 4, 2022—Biosensors International Group, Ltd. announced the enrollment of the first patient in the RISE SC study.

The single-arm, prospective, multicenter first-in-human trial is evaluating the acute safety and device success of the company’s semicompliant Rise SC coronary balloon when used as a dilatation device in the stenotic portion of a coronary artery or bypass graft in patients with coronary artery disease.

According to the company, the RISE SC trial will support the application for CE Mark approval of the Rise SC device. The study, which will include three investigational centers in Switzerland, will be led by Professor Marco Roffi, MD, who is Director of the Interventional Cardiology Unit at the University Hospital of Geneva, Switzerland.

The first patient treated with the device in the study was enrolled at the Hôpital du Valais of Sion in Sion, Switzerland. The patient was a male in his late 70s with a lesion in the left anterior descending artery. A 2.5- x 12-mm Rise SC balloon was used, and no complications were reported during the procedure.

The company noted that in most percutaneous coronary intervention procedures, predilatation is performed using semicompliant balloons at moderate pressure (8-10 atm) because they have a lower crossing profile than noncompliant balloons. The Rise SC balloon has been designed and developed to improve trackability and crossing profile and is aimed at having comparable performance to currently available best-in-class semicompliant balloons.

The Rise SC balloon is an investigational device and is not available for sale in any country, advised Biosensors. Biosensors, which is headquartered in Singapore, is the cardiovascular and neurovascular devices business of Bluesail Medical Co., Ltd., a subsidiary of China-based Bluesail Group.