Ovesco Endoscopy GmbH

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2007

December 2007 | Successful treatment of gastric perforation due to necrotizing pancreatitis with Ovesco’s OTSC clip

Clinical users of Ovesco’s OTSC clipping system report successful treatment of a gastric perforation after acute necrotizing pancreatitis. Dr. Andreas Kirschniak and colleagues at Tuebingen University Hospital, Tuebingen Germany, publish first case of endoscopic clip closure of a gastric perforation following pancreatitis described in the medical literature. No further operative treatment of the lesion was required
Full publication: Kirschniak A, Traub F, Kueper MA, Stüker D, Königsrainer A, Kratt T. Endoscopic treatment of gastric perforation caused by acute necrotizing pancreatitis using over-the-scope-clips: a case report. Endoscopy 2007; 39: 1100-1102

October 2007 | Ovesco Endoscopy GmbH was invited to the 2nd International NOTES Hands-On Course at IRCAD/EITS in Strasbourg, France; Ovesco's OTSC® system was enthusiastically embraced as an easy-to-use and effective instrument for reliable perforation closure after NOTES treatment

The IRCAD/EITS, a prestigious center of excellence for training and research, was one of the first institutions actively promoting the establishment of NOTES (Natural Orifice Transluminal Endoscopic Surgery) among respective clinical specialists. By entering the intraabdominal cavity with flexible endoscopic instruments through a natural orifice such as the mouth or the anus, the NOTES approach necessitates transgastric or transcolonic access ports. The reliable closure of these access ports is an essential step for NOTES to compete with minimally invasive strategies in terms of patient safety and complication rates.
With the OTSC® Over-The-Scope-Clipping System, Ovesco Endoscopy GmbH provides a novel endoscopic clipping system combining a high-force, big-bite NiTi endoscopic clip, for reliable grasping of large amounts of tissue and specific auxiliary instruments to manipulate the target tissue. The OTSC-System was originally developed for endoscopic haemorrhage of peptic ulcers and closure of perforations of the stomach or colon.
At the 2nd International Hands-On Course at IRCAD/EITS on October 12th and 13th, 2007, Ovesco's OTSC® System was successfully used by international experts, for transgastric port closure after NOTES procedure. Chi-Nghia Ho, R&D Manager at Ovesco Endoscopy GmbH, reported: "This was a completely successful introduction of the OTSC System to NOTES in front of an international audience. We consider this as prove of feasibility for our product and we will further optimize our system also for NOTES application."

July 2007 | Clinical partners of Ovesco present clinical experience with OTSC at the 15th Congress of the European Association for Endoscopic Surgery (EAES)

Athens, 4 - 7 July, 2007: Dr. Alberto Arezzo (International Evangelic Hospital, Genova, Italy) presents clinical experience with Ovesco’s OTSC clip at the EAES annual congress. Dr. Arezzo and colleagues have used OTSC successfully in a series of patients for the treatment of digestive tract hemorrhage and iatrogenic wall lesions, such as post-polypectomy lesions.

June 2007 | Clinical users of the OTSC clip publish data of first trial: full success rate regarding therapeutic goals

Clinical researchers of Eberhard-Karls University, Tuebingen Germany publish retrospective analysis of 11 patients in which Ovesco’s OTSC clip has been used in different indications. These indications include the treatment of GI bleeding of various origin, and the closure of deep gastric and colonic wall lesions and perforations. The desired therapeutic result was achieved in all patients and verified by re-endoscopy. Both the atraumatic and the traumatic version of OTSC have been used, depending on the anatomical location and condition to treat.
The retrospective analysis is part of Ovesco’s OTSC registry. The study was published in Gastrointestinal Endoscopy.
For the full study, please see: A Kirschniak, T Kratt, D Stüker, A Braun, MO Schurr, A Koenigsrainer. A new endoscopic over-the-scope clip system for treatment of lesions and bleeding in the GI tract: first clinical experiences. Gastrointestinal Endoscopy 2007; 66: 162-167

March 2007 | Pre-clinical approval of Ovesco`s dual jaw instrument for effective endoluminal closure of GI perforations is accomplished, e.g. for NOTES application

Ovesco`s novel dual-jaw grasper instrument together with the OTSC Clipping System enables endoscopist to manage perforation of the gastrointestinal tract (GI-tract) effectively. Perforation can occur in 0.2% (diagnostic) to 0.5-3% (therapeutic) of all colonoscopies, e.g. after snare resection during polypectomy. Perforation of the GI-tract is a serious complication which is conventionally treated by open surgery. Another field of application is the Natural Orifice Transluminal Endoscopic Surgery (NOTES). This new approach for endoscopic surgery needs commonly transgastric and\or -colonic ports which have to be closed after the interventional treatment. Chi-Nghia Ho, R&D Manager at Ovesco Endoscopy GmbH, describes briefly the innovation of the instrument: "Now it is possible to have two independently controllable graspers in one flexible instrument. Due to the special design of having two Bowden mechanisms each jaws can separately be opened\closed relatively to a third axial counter jaw. By grasping of the opposite sides of a perforation, the tissue can be aligned for easy and effective closing of the perforation using the OTSC Clipping System. This instrument has the potential to enable better treatment of severe complications and to broaden the field of flexible endoscopy."

January 2007 | Ovesco Endoscopy is consortium partner in EU project VECTOR

VECTOR is an innovative project supported by the European Union. 19 international partners from different backgrounds combine their expertise and efforts in order to develop the next generation of capsule technology. In the next four years, VECTOR will enhance today’s capsule technology with novel features for therapeutic treatment and diagnosis. As leader of the work package concerned with research and development of spin-off devices, Ovesco Endoscopy will play an important role in the project.
“We are glad to be a part of the VECTOR consortium. The project allows us to use our OTSC technology in such an innovative field and gives us the opportunity to use our creative capabilities and technological knowledge while continuously enhancing our know-how”, said Chi-Nghia Ho, R&D Manager of Ovesco Endoscopy GmbH.
The VECTOR project homepage offers more detailed information: www.vector-project.com

2006

December 2006 | Ovesco’s OTSC clip under clinical assessment at the Section of Surgical Endoscopy, Mannheim Hospital of Heidelberg University, Germany

Dr. Georg Kaehler, renowned surgical endoscopist and director of the Section of Surgical Endoscopy, Mannheim, has completed first cases in the management of upper gastrointestinal bleeding using Ovesco’s OTSC clip. OTSC is cleared for the EU market and is currently studied within the scope of an international post-market registry. “We are enthusiastic about our new collaboration with Dr. Kaehler and his co-workers. The Mannheim Section for Surgical Endoscopy with its complete spectrum of advanced endoscopic GI interventions is an ideal partner for us, both for evaluating our current products and for identifying future applications of our technology platforms”, said Prof. Dr. Marc Schurr, Founder and Managing Director of Ovesco Endoscopy GmbH.

September 2006 | OTSC clipping system now applied at the Digestive Endoscopy Unit, General Surgery, International Evangelic Hospital, Genova, Italy

Dr. Alberto Arezzo, International Evangelic Hospital, Genova has joined Ovesco OTSC clip study group. The study is part of an ongoing post-market registry. "Dr. Arezzo, who had also been involved into the development of the OTSC technology, is a highly esteemed clinical partner for us, and we are happy to cooperate with him on expanding the clinical scope of our OTSC system", said Prof. Dr. Marc Schurr, Founder and Managing Director of Ovesco Endoscopy GmbH.

August 2006 | Ovesco Endoscopy announces begin of clinical use of its OTSC clipping system at the Humanitas Hospital, Milan / Rozzano, Italy

Dr. Alessandro Repici, Director of Digestive Endoscopy at Humanitas Private Hospital, and Ovesco Endoscopy have started a pilot study on Ovesco’s OTSC clip for different endoscopic procedures, e.g. post-polypectomy bleeding and other applications in the lower and upper gastrointestinal tract. The study is part of an ongoing post-market registry, managed for Ovesco Endoscopy by novineon CRO, a contract research organization specializing in medical technology.
"We are glad to work with Dr. Repici, a European leader in gastrointestinal endoscopy, in clinical research and we are looking forward to our cooperation with Dr. Repici and the renowned Unit of Digestive Endoscopy at the Humanitas Hospital", said Prof. Dr. Marc Schurr, Founder and Managing Director of Ovesco Endoscopy GmbH.

July 2006 | Clinical partners of Ovesco Endoscopy GmbH receive Karl Storz award at the CAES Symposium in Rostock, Germany

Research on the OTSC clipping system of Ovesco Endoscopy wins prize at the 45th Symposium of the Surgical Working Group for Endoscopy and Ultrasound (CAES) of the German Society for Surgery, held in Rostock, Germany, June 16-17 2006.
Dr. Andreas Kirschniak and coauthors, Surgical Endoscopy Unit, Department of Surgery, Eberhard-Karls University, Tuebingen, Germany, were honored with the Karl Storz award for their research on the OTSC endoscopic clipping system in the treatment of bleeding and perforations in digestive endoscopy.

June 2006 | Ovesco Endoscopy announces first clinical applications of its OTSC clipping system at Tuebingen University Hospital, Germany

Following market clearance earlier this year Ovesco Endoscopy’s OTSC clipping system has been used in a series of cases at the Endoscopy Unit of the Department of Surgery at Tuebingen University Hospital. Dr. Andreas Kirschniak, co-founder of Ovesco Endoscopy and colleagues at Tuebingen University Hospital successfully used the OTSC clip in procedures, such as the treatment of colonic lesions and GI bleeding as part of an ongoing post-marketing clinical study.

March 2006 | Ovesco receives CE mark and market clearance for its OTSC endoscopic clipping system in the European Union

The OTSC clipping system is regulated as a class 2b product, according to the directive 93/42 EEC. Ovesco Endoscopy GmbH is regularly audited by its Notified Body DEKRA Certification GmbH, Stuttgart, Germany (CE 0124).

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