A team at the Mount Sinai Fuster Heart Hospital has successfully performed the first procedure in the United States using an innovative drug-eluting, below-the-knee resorbable scaffold.
The team was led by Prakash Krishnan, MD, FACC, FSCAI, Assistant Professor, Medicine (Cardiology and Radiology), and Director of Endovascular Interventions at The Mount Sinai Hospital’s Cardiac Catheterization Laboratory. The Food and Drug Administration approved the device in April.
“FDA approval of this long-awaited new technology of a dissolving bioabsorbable scaffold is a remarkable addition in the treatment of lower limb arterial blockages where balloon and regular stents results are suboptimal, and these scaffolds are poised to restore blood flow for a long time,” says Samin K. Sharma, MD, Director of Interventional Cardiology for the Mount Sinai Health System. “We are proud of Dr. Krishnan, who played a major role in getting this innovative device approved.”
More than 20 million people in the United States are living with peripheral artery disease (PAD) yet there have been limited treatment options. The new procedure is the first to treat people with chronic limb-threatening ischemia (CLTI) below-the-knee, a severe stage of PAD. The goal is to prevent amputation, heart attack, and stroke among these patients.
For individuals battling chronic limb-threatening ischemia, blocked vessels restrict blood flow to the lower extremities. While balloon angioplasty serves as the current standard of care, recurrent blockages often necessitate further intervention.
Unlike traditional metal stents, the drug-eluting below-the-knee resorbable scaffold is a temporary implant. Crafted from naturally dissolving material, this scaffold gradually disappears after opening a clogged artery, presenting a significant advancement in sustaining open arteries below the knee.
“A resounding applause to the team at Mount Sinai Fuster Heart Hospital for their relentless pursuit of excellence in advancing patient care,” said Dr. Krishnan. “Many times doctors tell patients amputation is the only option, so this new technology is a game changer.”