Lumendi, a pioneering manufacturer of endosurgical solutions, today announced the successful completion of customer evaluations of its DiLumen EZ¹, the U.S. Food and Drug Administration (FDA) 510(k)-cleared, single-use, disposable endotherapy device for procedures such as endoscopic mucosal resections (EMR) and difficult colonoscopies, and the newest addition to the company’s DiLumen suite of products. This milestone is indicative of the company’s consistent growth and innovation.
Peter Johann, Chief Executive Officer of Lumendi, noted, “Our products are designed to provide an edge in tackling the complexities of polypectomies, thereby improving patient outcomes and delivering higher curative rates. That said, the positive customer response to the DiLumen EZ¹ is a testament to our commitment, and our ability to deliver transformative solutions for challenging gastrointestinal interventions.”
The DiLumen EZ¹ is the first in a series of planned, strategic product additions and Lumendi is currently starting the evaluation phase of a second, FDA 510(k)-cleared product, the DiLumen C1. This next-generation solution is designed to facilitate complex polyp procedures in the colon and rectum, such as endoscopic submucosal dissection (ESD). This aligns with Lumendi’s vision of integrating robotic-like tools into complex GI procedures, with the aim of mainstreaming these interventions and accelerating the learning curve of advanced GI practitioners.
“By continuously expanding our product portfolio, we move closer to becoming the partner of choice for GI practitioners dealing with complex polypectomies,” Dr. Johann stated. “This includes offering the EZ-Glide, our versatile solution for lower bowel procedures, suitable for most polypectomy interventions, which has been commercially available in the U.S., EU, the UK and Asia since 2017.”
Dr. Stavros Stavropoulos, Chief of Endoscopy and Director of the program in Advanced Gastrointestinal Endoscopy and Endoscopic Surgery at Archbold Medical Center, and a key opinion leader in the field, added, “As a physician dedicated to the development and introduction of cutting-edge, advanced endoscopic surgery technologies, I believe that Lumendi’s suite of DiLumen devices represent an important advancement in the field. With increasing adoption over time, they hold the potential to drive a shift away from more invasive surgery toward minimally invasive endoluminal procedures. This should lower complication rates, require little to no hospital stay and significantly reduce recovery times for patients.”