FDA Approves Boston Scientific’s (NYSE:BSX ) Ranger™ DCB In Peripheral Artery Disease

Boston Scientific (NYSE:BSX) has announced that the US FDA has approved the Ranger™ Drug-Coated Balloon. It is under development to treat patients having peripheral artery disease in the superficial femoral and proximal popliteal arteries.

PAD affects 200 million people globally

PAD is a circulatory problem that leads to the building up of plaque and narrowing of arteries resulting in reduced blood flow to limbs. It affects around 200 million people globally. Boston Scientific’s Ranger™ DCB has been designed with a low drug dose and novel coating that efficiently transfers the drug into the tissue. This results in high primary patency rates with low systemic treatment exposure. The balloon’s low-profile platform helps clinicians streamline procedures and also navigating challenging anatomy to deliver consistent therapy.

Jeff Mriviss, the president of Peripheral Interventions, Boston Scientific, said that this approval allows the company to deliver exceptional treatment options to patients. These are therapies with proven safety to physicians and patients facing PAD. Mirviss added that the addition of Ranger DCB to Boston Scientific’s drug-eluting portfolio reinforces the company’s dedication to offering differentiated tech with substantial clinical evidence.

Ranger II SFA trial data used to grant approval

The FDA approved Ranger™ DCB based on data from the company’s pivotal RANGER II SFA trial. The study evaluated the efficacy and safety of Ranger DCB compared to standard percutaneous transluminal angioplasty in treating patients with PAD in the PPA and SFA. The randomized controlled study met both primary endpoints, with the primary safety endpoint of 12-month freedom from adverse events being 94.1% for those that received Ranger DCB. On the other hand, there was a low target lesion revascularization rate in patients that received Ranger DCB therapy.

The study’s lead investigator Ravish Sachar said that Ranger™ DCB is vital in easing deliverability for various lesion complexities. It does so through a low profile platform compatible with small thickness guidewires with consistent results for several randomized controlled studies. Sachar added that data shows that Ranger DCB is an effective and safe treatment alternative for physicians that want to limit systemic drug loss.