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November 27, 2018

SafeHeal reports positive results from clinical study of Colovac device

French medical device company SafeHeal has reported positive results from a clinical study conducted for its Colovac bypass sheath in patients undergoing colorectal surgery.

French medical device company SafeHeal has reported positive results from a clinical study conducted for its Colovac bypass sheath in patients undergoing colorectal surgery.

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The first-in-human single-arm 15-patient study was aimed at evaluating the safety and efficacy of the Colovac device in the protection of colorectal anastomosis in adult patients.

During the study phase, patients received a Colovac implant for a period of two weeks, in place of a diverting ostomy.

“The Colovac device, an endoluminal bypass sheath, is placed in the colon following rectal resection and is intended to suppress contact between faecal matter and the colorectal anastomotic site.”

The minimally invasive and fully reversible device can remain in place until the completion of the body’s natural healing and tissue repair processes. During an endoscopic procedure, it can be easily removed avoiding a second surgical intervention.

SafeHeal noted that appropriate protection against direct contact with faeces at the time of implant was accomplished in all cases.

The placement, as well as retrieval procedures, have also proven to be safe and effective.

SafeHeal CEO Karl Blohm said: “The study shows that our Colovac bypass device can successfully reduce the number of diverting ostomies for patients undergoing colorectal surgery.

“The trial results will allow us to design the next clinical phase as well as our strategy for regulatory approvals in the EU and the US.”

The study found that 67% of participating patients successfully avoided diverting ostomies. Furthermore, it was revealed that Colovac might improve the quality of life of surgery patients.

The study was conducted at two hospitals in France (Institute of Image-Guided Surgery in Strasbourg in collaboration with the CHRU Strasbourg and Saint Antoine Hospital, APHP in Paris) and at UZA in Belgium.

The Colovac device, an endoluminal bypass sheath, is placed in the colon following rectal resection and is intended to suppress the amount of contact that faecal matter has with the colorectal anastomotic site.

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Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
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