DiLumen Ik™ Endolumenal Interventional Knife Receives 510(k) Clearance

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Lumendi, LLC announced today it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the DiLumen Ik Endolumenal Interventional Knife, a sterile, single-use, disposable monopolar electrosurgical device for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures. The DiLumen Ik is also designed to deliver a seamless submucosal injection to create and maintain a fluid cushion during tissue dissection. This is the seventh device Lumendi has developed as the company continues to advance minimally invasive endolumenal therapies.

Lumendi also reports that, to date, clinicians in the U.S., several EU countries including Germany, France, Italy, Spain and the U.K., as well as at the Chinese University of Hong Kong, have completed over 1,000 procedures with the commercially available DiLumen Endolumenal Interventional Platform (EIP). Three clinical studies using the DiLumen EIP have also been completed — further demonstrating safety and cost effectiveness — and will be published soon.

The DiLumen Ik knife is part of a growing platform of accessories that work in conjunction with the second-generation DiLumen C2 EIP, which is designed to provide complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment.

Other DiLumen accessories are:

  • Ig Endolumenal Interventional Grasper, a flexible endoscopic tool intended to grasp and manipulate tissue within the digestive tract under direct endoscopic visualization.
  • Is Endolumenal Interventional Scissors, a sterile, single-use, disposable monopolar electrosurgical device for mechanical and electrocautery cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures.
  • Im Endolumenal Intervention Mount, an ergonomically designed workstation that will support the various accessories and allow the clinician to perform procedures in a more comfortable standing or seated position.

“We are responding to the needs of endoscopists by continuing to improve and develop the DiLumen platform of devices. In addition, we are also developing products and applications for the colon and the upper GI tract with the ultimate goal of reducing and replacing invasive open or laparoscopic surgical procedures,” said Dr. Peter Johann, CEO, Lumendi, Ltd.

Adequate tissue manipulation and traction, combined with effective cutting, dissecting and cauterizing, continues to be a major challenge for therapeutic procedures in the digestive tract. These new Endolumenal Interventional Instruments are based on Lumendi’s initiative to improve access and tissue manipulation in the colon to help move many gastrointestinal surgeries to less invasive endolumenal procedures.

The DiLumenEIP consists of a single-use, soft flexible sheath that fits over standard and small-diameter endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second that can extend in front of the tip of the endoscope once at the lesion site. When both balloons are deployed and inflated, a stable Therapeutic Zone (TZ) is created. This TZ facilitates more localized insufflation and manipulation of the colon and may provide better access to lesions. With the addition of two working channels for DiLumen Ig and DiLumen Is or the new Ik tissue can be manipulated, cut and dissected in a way that may improve removal of lesions during endolumenal interventions.

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