|LuxCath sensor--Courtesy of LuxCath|
Boston's LuxCath touted results from the first-in-man study of its sensor to visualize lesions during cardiac ablation, saying the additional feature successfully monitored ablation lesions as they were being created in all 11 patients.
The company believes it has demonstrated feasibility of the sensor and is now looking to partner with an ablation company to bring it to market, said LuxCath CEO Dr. Omar Amirana in an email to FierceMedicalDevices, adding "regulatory paths will hinge on business outcomes."
Arrhythmias (irregular heartbeats) treated include atrial flutter, AV nodal re-entrant tachycardia, and atrial fibrillation.
LuxCath says its optical tissue interrogation technology is the only sensor embedded into ablation catheters to provide real-time information about the tissue under the surface of the heart during ablation procedures. Temperature and pressure sensors provide information about the catheter's electrode or the interface of the electrode and the tissue, the company says.
The LuxCath sensor can also be used as a standalone catheter. It provides information about tissue contact and enables lesion formation assessment, potentially reducing procedure times and arrhythmia recurrences, according to a release.
"In all 11 patients, the technology identified tissue contact and was easy to use. In a wide variety of settings, we were able to assess and monitor ablation lesions as they were being created. There were no complications," said electrophysiologist Dr. Vivek Reddy, who led the investigational procedures, in a statement. "This is an exciting step forward in the world of ablation. Based on our experience, the technology platform is quite promising."
Reddy is director of arrhythmia services at New York City's Mount Sinai Hospital. The study was conducted at Homolka Hospital in Prague.
Although the sensor has applications to all forms of cardiac ablation, LuxCath is focusing on using it to treat atrial fibrillation, the most common arrhythmia, which affects more than 2 million people in the U.S., leading to strokes, thromboembolic events and heart failure.
The company was founded in 2012 based on research performed at the George Washington School of Medicine and Health Sciences.
LuxCath is a portfolio company of Allied Minds, a Boston-based holding company for developers of early-stage technology from U.S. universities and federally funded research institutions.
- read the release