BD today announced it started enrollment in the first-in-human trial of a peripheral sirolimus drug-coated balloon (DCB).
The Prevision trial is a prospective, multi-center, single-arm, non-randomized study that will evaluate the safety of BD’s DCB in the treatment of peripheral arterial disease (PAD) in the femoropopliteal arteries. The company initiated the trial to determine the viability of sirolimus as a treatment option for people with PAD.
“PAD impacts more than 200 million people across the globe and is often associated with morbidity, functional declines and higher health care costs. BD is committed to delivering much-needed solutions to address these challenges,” said Paddy O’Brien, worldwide president of BD peripheral intervention. “The launch of our Prevision first-in-human study demonstrates our ongoing commitment to advancing the drug-coated balloon category. It marks an important milestone on the path towards bringing this technology to clinicians and patients around the globe.”
BD’s first patient in the study was successfully treated by Dr. Andrew Holden, principal investigator at Aukland City Hospital in New Zealand.
“It is an honor to enroll the first patient in the Prevision study,” said Dr. Holden. “The burden of PAD continues to impact patients and challenge physicians around the globe. A continued focus on developing next-generation technology is important for the patients suffering from PAD.”
The Prevision trial will be conducted across multiple sites in Australia, New Zealand and Singapore. The trial will enroll and follow up on approximately 50 patients.
BD was one of the first companies to receive FDA approval for a paclitaxel drug-coated balloon in 2014. It has continued to innovate the balloon technology with advances such as additional indications, lower sheath profile, longer treatment lengths and additional guidewire configurations. The technology is currently used as an endovascular interventional treatment option for patients with PAD in the femoropopliteal arteries.
