Lumendi secures FDA 510(k) approval for DiLumen EZ¹ and DiLumen C¹ devices

2023-02-17

上市批准

The DiLumen EZ¹ and DiLumen C¹ devices are used together with endoscopes and gastroscopes, to support navigational access, optical visualisation, diagnosis and endotherapeutic treatment procedures in the large intestine DiLumen C1 with atraumatic grasper. (Credit: Lumendi, LLC) US-based medical device company Lumendi has received the US Food and Drug Administration (FDA) 510(k) clearance for its new devices, DiLumen EZ¹ and DiLumen C¹. Lumendi said that its DiLumen EZ¹ and DiLumen C¹ constitute its platform of accessories that are used together with endoscopes and gastroscopes, for procedures in the large intestine. The two new devices support navigational access, optical visualisation, diagnosis and endotherapeutic treatment, said the company. DiLumen EZ¹ is a single-use, disposable endotherapy device designed to aid endoscopic mucosal resections (EMR) and difficult colonoscopies. It comes with a modified and streamlined design, based on the success of the DiLumen EZ-Glide platform, to be more cost-effective, said the medical device company. Lumendi chief executive officer Peter Johann said: “The DiLumen EZ¹ device will meaningfully enhance our product portfolio by meeting more procedure-specific needs for complex polyp resections which are conducted through EMR. “Globally, EMR procedures represent the majority share of the over one million polyp resections conducted, annually.” DiLumen C¹ is designed to facilitate complex polyp resection in the colon and rectum through endoscopic submucosal dissection (ESD). Its unique design provides a single working channel that can accommodate an atraumatic grasper, to enable more direct tissue manipulation and traction. The use of DiLumen C¹, together with atraumatic grasper, will help improve the curative removal of precancerous and non-invasive cancerous polyps during ESD. According to the company, inadequate stability, tissue manipulation and traction, along with ineffective cutting, dissecting, and cauterizing is a major challenge to therapeutic procedures in the digestive tract. Its DiLumen EZ¹ and DiLumen C¹ devices now form a complete set of instruments to perform any complex polypectomy and other interventions in the entire colon. Johann added: “Since 2017, clinicians in the US, EU, the UK, and Asia, have completed over 4,000 procedures with the commercially available DiLumen EZ Glide. “These newest devices, when combined with the increasing market adoption of DiLumen EZ Glide, will accelerate Lumendi’s continued vision to shift procedures away from invasive gastrointestinal surgeries, towards endoluminal procedures with lower complication rates, little to no hospital stays and very minimal recovery times. “In addition, based on our success impacting therapeutic procedures in the colon and using our current technology, we will look to expand our development program into upper GI interventions, which we expect will lead to better patient outcomes.”

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