Mount Sinai reports first use of drug-coated balloon catheter to treat patient with PAD

The Mount Sinai Hospital is the first to use a new drug-coated balloon catheter that was recently approved by the FDA for the treatment of peripheral arterial disease, according to a press release.

Prakash Krishnan, MD, FACC, director of endovascular services at Mount Sinai Heart, along with Jose Wiley, MD, FACC, and Bhaskar Purushottam, MD, also from Mount Sinai, were the first doctors in the United States to perform a procedure incorporating the Lutonix 035 drug coated balloon catheter (Lutonix DCB; Lutonix Inc./C.R. Bard) after it was approved by the FDA on Oct. 10.

The device is intended for use during angioplasty among patients with severely blocked femoro-popliteal arteries due to PAD. The Lutonix DCB, which includes a balloon coated with paclitaxel to prevent restenosis, opens the blocked artery while applying paclitaxel to the artery wall.

Krishnan was principal investigator at Mount Sinai Hospital for the global, randomized LEVANT 2 pivotal study, which evaluated the catheter during angioplasty in comparison with standard therapy with a non-drug-coated balloon catheter. Results after 1 year indicated improved artery blood flow, increased patient mobility and reduced incidence of blood clots, according to the release. Mount Sinai was one of 54 sites worldwide that participated in LEVANT 2.

“This drug-coated balloon may be a game-changer in the management of patients with PAD,” Krishnan said in the release. “It can effectively reduce the recurrence of blockages in patients, which can help prevent limb amputations, improve a patient’s quality of life and also be life-saving.”

Disclosures: Krishan reports serving consulting for C.R. Bard Inc.