BD and Abbott expand interventions in peripheral arterial disease

MedTech & Diagnostics News: In evaluating the efficacy and safety of a vascular covered stent in the treatment of peripheral arterial disease (PAD), BD (Becton, Dickinson and Company) has kicked off the AGILITY clinical trial in Australia as part of a global study.

PAD is a narrowing of the arteries that causes reduced blood flow in an area of the body other than the heart or brain, and affects almost one in every five Australians. While PAD is not immediately life threatening, someone with PAD is up to six times more likely to have a heart attack or stroke.

Dr Sean Lyden, chairman of the Department of Vascular Surgery at Cleveland Clinic and the National Principal Investigator of the AGILITY study, said “When we’re addressing advanced PAD, a self-expanding covered stent can play an important role. We need a stent that can track to the lesion, apposes the vessel wall and ultimately provides long-term durability. We’re excited to see how this technology performs.”

The single-arm, non-randomised AGILITY study is set to enrol 315 patients across up to 40 clinical sites spanning Australia, New Zealand, United States and Europe. The trial commenced earlier this month, with patients set to undergo follow-up assessments up to 36 months post-treatment.

“There continues to be significant unmet needs in the treatment of PAD patients,” stated Tim Hug, vice president and general manager at BD Peripheral Intervention. “This stent could give interventionalists an important new solution in the fight against PAD, expand our portfolio and enable us to better serve our customers and the patients they treat.”

On the local front, Conjoint Associate Professor Ramon Varcoe, from UNSW Medicine & Health and vascular surgeon at the Prince of Wales Hospital, collaborated with Abbott to develop Esprit BTK, a medical technology targeting blocked arteries below the knee.

“Currently, we use angioplasty but this has no mechanical scaffolding properties and usually doesn’t stay open very long,” A/Professor Varcoe explained.

Esprit BTK offers a mechanical scaffold infused with everolimus, a drug aimed at preventing blood vessel narrowing. The scaffold dissolve harmlessly within the body over 18-24 months, a useful quality as the artery only needs to be held open for a limited time to restore blood flow and resolve the blockage.

The Phase 3 randomised controlled trial for Esprit BTK, involving 261 patients globally, yielded promising results. Patients treated with Esprit BTK showed a 75% success rate in maintaining artery patency at the one-year mark, a stark contrast to the 44% success rate observed in the balloon angioplasty group.

“The Esprit scaffold gives mechanical support to the recently opened artery, it delivers a drug to the blood vessel wall that prevents renarrowing, and then it dissolves, leaving nothing behind to irritate the blood vessel and induce scar tissue formation,” A/Professor Varcoe highlighted. “It also avoids burning bridges should the patient require bypass surgery in the future.”

Abbott spearheading efforts to make Esprit BTK accessible to patients in Australia and globally.

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