Clinical-stage medical device company SafeHeal has concluded a first-in-human clinical study for its Colovac bypass sheath in patients undergoing colorectal surgery.
The study showed that 67% of participating patients successfully avoided diverting ostomies and returned home without an artificial anus, with results of the trial suggesting the device might improve the quality of life of surgery patients.
The single-arm 15-patient study was aimed at evaluating the safety and efficacy of Colovac in the protection of colorectal anastomosis in adult patients who were scheduled to receive a diverting ostomy, following colorectal surgery.
The study took place 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 Antwerp, Belgium.
Professor Jérémie Lefevre of Saint Antoine Hospital said: “The clinical results of this trial provide initial evidence that the Colovac device will be a suitable substitute for a significant number of diverting ostomies. This new treatment will help us to avoid the burden of living with an artificial anus, associated comorbidities and related closure surgery for the majority of patients who today require an ostomy.”
Every year about 270,000 colectomy patients in Europe and the USA receive an ostomy, with a substantial market potential and considerable medical need for devices such as Colovac.
The Colovac device is an endoluminal bypass sheath placed in the colon following rectal resection, aimed at suppressing contact of faecal content with the colorectal anastomotic site. It is anchored upstream of the anastomosis, using a stent combined with an innovative vacuum-based mechanism. It can remain in place until the body’s natural healing and tissue repair processes are complete, which could last up to two weeks.
Karl Blohm, CEO of SafeHeal 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.”
