S4 Medical Receives FDA 510(k) Approval for its Redesigned Esophageal Deviation Device and Begins Commercialization
CHAGRIN FALLS, OH / ACCESSWIRE / November 25, 2024 / S4 Medical Corp, an Ohio based company committed to making atrial fibrillation (AF) ablation procedures safer, has received 510(k) approval by the U.S. FDA for its redesigned esolution® esophageal deviation device. S4 Medical now has the first and only FDA approved device to prevent ablation-related esophageal injury in all ablation modalities.
Following receipt of the FDA’s De Novo approval last year, S4 Medical engaged in a product redesign effort for large scale manufacturability of the device, while also considering usability improvements. With this latest 510(k) approval, S4 Medical can now focus on launching its esolution device to a broad network of healthcare systems in the United States. Thermal injury to the esophagus is a feared complication associated with all AF ablation procedures that can lead to atrioesophageal fistula (AEF), which, though rare, is associated with a high mortality rate.
S4 Medical’s pathway to approval began with a multi-center, randomized, double-blinded, prospective IDE trial (“EASY AF” Study). To date, no other company has performed this type of study despite the longstanding concern for this clinical complication. The trial treated 120 patients at eleven study centers in the U.S. and one international site. The study demonstrated a statistically significant reduction in thermal injury to the esophagus during AF ablation procedures with no limitations on ablation power or technique. The data showed thermal injury with wide-ranging severity in 35% of control patients who did not receive the esolution device; patients receiving the device had injury prevalence reduced by 84% (p-value < 0.0001).
S4 Medical’s recent 510(k) approval opens a new chapter for the company to begin its commercial phase. “To date S4 has exclusively been focused on innovation and clinical research,” says cofounder and CEO, William Fuller, “the launch of esolution will benefit the majority of AF ablation procedures with enhanced safety and reduced procedure time.” The EASY AF Study noted significant interruptions in the control group related to esophageal safety. “Physicians look for strong safety and efficacy data when considering new technologies – the esolution delivers on this.”
S4 Medical’s latest receipt of approval comes amidst enthusiasm of a new ablation modality known as Pulsed-Field Ablation (PFA), which has been marketed as an alternative approach to existing ablation options. PFA does not come without concerns related to complications, long-term efficacy, cost, and even availability. “Throughout my career, I’ve seen innovation across all aspects of AF ablation… this will continue as we strive to perfect treatment options,” notes S4 Medical’s cofounder and Chief Medical Officer, Emile Daoud, MD. “Whatever the future holds for AF treatment options, one thing is certain… it’s essential that we prioritize patient safety.”
Newer techniques referred to as high power/short duration (HPSD) radiofrequency ablation have been widely adopted. Some manufacturers have introduced ablation catheters specifically designed for this technique with vastly higher power delivery capabilities. As S4 Medical launches into the AF ablation market, the company believes HPSD will be a specific focus area for improved safety. “We are confident that physicians will embrace the clinical advantages of pairing the esolution device with the HPSD approach,” says Ron Farnham, S4 Medical’s Vice President of Business Development.
About S4 Medical Corp: S4 Medical Corp is a medical device company focused on innovative solutions for cardiac procedures. The company’s initial product is a simple solution intended at reducing complications to the esophagus during catheter ablation procedures for AF. S4’s team is motivated by making medical procedures safer and more effective.
CONTACT:
Ron Farnham
Ron@S4medical.com
SOURCE: S4 Medical Corp
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