Dive Brief:

• BD started a clinical trial of its investigational vascular covered stent in people with peripheral arterial disease (PAD). 
• The study is enrolling 315 patients to evaluate the safety and effectiveness of the self-expanding nitinol implant with a fluoropolymer coating.
• BD already sells a range of medical devices for PAD, including the self-expanding Lifestent, but has identified a need for a durable stent that tracks the lesion and sits next to the vessel wall.

Dive Insight:

BD’s single-arm clinical trial recently enrolled its first patient at a site in Iowa. The site is one of up to 40 that BD plans to activate across the U.S., Europe, Australia and New Zealand as it works to enroll PAD patients and track them for 36 months.

Sean Lyden, chairman of the department of vascular surgery at Cleveland Clinic and national principal investigator of the study, outlined the need for the technology in a statement, explaining that physicians still want “a stent that can track to the lesion, apposes the vessel wall and ultimately provides long-term durability.”

Stephanie Klocke, vice president of R&D, peripheral intervention at BD, discussed the technology during a webcast on PAD in late February. Klocke said the device “will truly be exciting for physicians, very beneficial for our patients and, of course, for [our] business.”

The stent is “one more tool to add to the toolkit ... especially when treating really complex PAD patients,” Klocke said.

If the device comes to market, it will slot into a portfolio of products that are central to BD’s strategy to grow the business through 2025. The company has identified peripheral vascular disease as one of six key platforms where it can achieve a weighted average market growth rate in the high single-digits. 

On an earnings call in early February, BD CFO Christopher DelOrefice said the company continues to “drive market penetration” in peripheral vascular disease with its Rotarex atherectomy system and venous portfolio. BD acquired the Rotarex technology in its 2020 takeover of Straub Medical.