dimarts, 29 de maig del 2018

LuxCath eyes the atrial fibrillation market

LuxCath

One problem with using ablation to treat atrial fibrillation is determining when the resulting lesion is sufficient to block the electric signals underlying the arrhythmia.

LuxCath thinks its OmniView catheter solves the dilemma by using an optical technology to assess metabolic activity in the ablated tissue, CEO Dr. Omar Amirana told MassDevice.com earlier this month during the annual Heart Rhythm Society meeting in Boston.

Amirana, a senior vice president at Allied Minds (LON:ALM), also helms Allied Minds subsidiaries SciFluor and Signature Medical and is a board member at CardioFocus. What drew him to LuxCath, he told us, is its ability to both visualize the ablated tissue and assess its viability.

“I’ve been an electrophysiologist since 1992 and I have not been able to find a technology that actively can see a lesion, in real time,” Amirana said. “This looks into the tissue, whereas everything else we’re looking at is right on the surface of the tissue, so you don’t have an idea of what’s going inside the wall of the muscle, and that’s really where recurrences occur.

“It’s kind of like a stud finder. If you’re looking for where to put the nail, basically, we tell you where the stud is,” he explained.

OmniView uses an optic fiber threaded through the catheter to shine light into the myocardium. If there’s poor contact with the catheter, the device doesn’t return a signature, Amirana explained. But if there’s good contact, the returning light excites a specific molecule that delivers information on tissue composition and lesion quality.

“It tells us whether we’ve got collagen and elastin in the tissue or whether we’ve got a healthy dose of viable myocardium that’s capable of conducting,” he said. “The way we determine that is we’re looking at the fluorescence properties of collagen which fluoresces at one wavelength and the fluorescence of [nicotinamide adenine dinucleotide], which is a molecule that’s inside metabolically active cells that’s required for basic metabolic activity.”

“What we’ve done essentially is added ports to the end of the catheter tip, so that we’re not only interrogating tissue that’s perpendicular, we’re interrogating all angles of contact. The big take-away for that is we’re not only going to assess catheter stability at all angles of contact and assess tissue composition, but also measure progression,” added LuxCath GM Arun Jaganathan.

With enough funding to carry through to CE Mark approval in the European Union, expected some time next year, and an 11-case first-in-human series under its belt using a prototype, Luxcath is developing the next iteration of OmniView and a clinical program to back the CE Mark bid and a parallel application with the FDA, Amirana said.

Dr. Vivek Reddy, who performed the first-in-human study, told us that although it’s early days yet, the OmniView catheter addresses an important gap in the EP toolbox.

“We assume that we’re ablating tissue based on the fact that electrograms diminish. But that’s a very crude way of interrogating information,” Reddy explained. “LuxCath is using a very clever way. Myocardium has a lot of [nicotinamide adenine dinucleotide]. So when you’re touching tissue, you suddenly see this peak of [nicotinamide adenine dinucleotide] and then when you ablate the tissue, that disappears. It’s an approach that will give you both contact information, as well as following lesion progression. I think it’s a very interesting, exciting one.”

The post LuxCath eyes the atrial fibrillation market appeared first on MassDevice.



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