Laser atherectomy system safe, effective in first-in-humans study

John R. Laird Jr.

LAS VEGAS — A laser atherectomy system for treatment of peripheral artery lesions was safe and effective in a first-in-humans study, researchers reported at VIVA 18.

The system (B-Laser, Eximo Medical) received FDA clearance in October. John R. Laird Jr., MD, medical director of the Adventist Heart and Vascular Institute in St. Helena, California, and a Cardiology Today’s Intervention Editorial Board Member, presented 12-month data here from one of the two studies the clearance was based on.

“There are a number of unique features of this particular laser which offer advantages over the other commercially available laser-based platform,” Laird said during a press conference. “This is a small and light solid-state [neodymium-doped yttrium aluminum garnet] laser with a unique 355-nm wavelength. It has a very short pulse width, 10 nanoseconds, which allows significant energy delivery into the vessel. It has threefold affinity to lesion-type tissue vs. the artery’s endothelium, making the risk of perforation lower. Catheter sizes are available to allow both above-the-knee and below-the-knee intervention. And the device is very effective for calcified lesions because of the short pulse width.”

For the first-in-human trial, the device was used on 50 patients (mean age, 64 years; 76% men) at two centers in Poland.

The primary safety endpoints were freedom from major adverse events at 30 days and freedom from device- and procedure-related events before discharge. The primary technical endpoint was ability to cross the target lesion stenosis over the wire.

All patients were Rutherford class 2, 3 or 4 and the mean ankle-brachial index was 0.57.

Mean lesion length was 7.4 cm, 88.2% of patients had calcified lesions and 84.9% of patients had lesions in the superficial femoral artery.

All patients underwent balloon angioplasty, 20% had a drug-coated balloon used and 36% had a stent implanted, Laird said.

There were no device-related complications or major adverse events at 30 days or 6 months, Laird said, noting that there were two major adverse events, both target lesion revascularization, between 6 and 12 months, so 12-month freedom from TLR was 96%.

Mean stenosis percentage declined from 93.6% at baseline to 58.7% after atherectomy to 14% after adjunctive therapy, according to the researchers.

Mean ankle-brachial index improved to 0.94 at 30 days, 0.84 at 6 months and 0.76 at 12 months, Laird said.

The average Rutherford class improved from 2.9 at baseline to 1.02 at 12 months, whereas the average Walking Impairment Questionnaire score improved from 36.78 at baseline to 58.42 at 12 months, he said.

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“This is a promising first-in-man experience with a new laser technology for debulking lesions in the peripheral circulation,” Laird said during the press conference. “It has the ability to treat all types of lesions, including heavily calcified lesions, and showed an excellent safety profile in this initial experience.” – by Erik Swain

Reference:

Laird JR, et al. Late-Breaking Clinical Trials. Presented at: VIVA 18; Nov. 5-8, 2018; Las Vegas.

Disclosure: The study was funded by Eximo Medical. Laird reports he received honoraria from Medtronic; received consultant fees from Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, Medtronic and Reflow Medical; and holds equity in Angioslide, Eximo, P.Q. Bypass, Reflow Medical, Shockwave Medical and Syntervention.