Colovac - Flexible Endoluminal Bypass Sheath for Health Professionals
Invented by French surgeon Charam Khosrovani, Colovac is a flexible endoluminal bypass sheath that prevents contamination of the colorectal anastomotic site following open or laparoscopic colorectal surgery. Minimally invasive and fully reversible, Colovac is anchored by a vacuum seal above the anastomosis and can be removed during a routine endoscopic procedure. Clinical trials support Colovac’s effectiveness in improving and expediting patients’ recoveries from surgery. This is an especially important benefit for surgeons, clinicians, payors and postoperative care professionals, and for the community of colorectal patients worldwide.
Clinical Benefits
Every year, two million colorectal surgical resections are performed worldwide. In the healing phase after these surgeries, anastomotic leakage is a serious potential complication. To minimize the clinical impact of an anastomotic leak, for most low rectal resections a temporary diverting ostomy is created. Temporary diverting ostomy can lead to post-surgical complications, such as dehydration, stoma-site hernia, bowel obstruction, and skin irritation. Temporary diverting ostomy is known to negatively impact patient satisfaction and quality of life, and a significant number of temporary diverting ostomies are never reversed, thus creating a permanent burden for patients.
Following extensive preclinical testing, Colovac underwent first-in-human clinical trials at the IHU/CHRU in Strasbourg, University Hospital Antwerp and Hôpital Saint-Antoine in Paris. During this pilot study, patients received a Colovac implant for two weeks, in place of a diverting ostomy. In all cases, appropriate protection against direct contact with feces during the implant period was accomplished.
The placement and retrieval procedures have also proven to be safe and effective.
67% of participating patients successfully avoided diverting ostomies.
Results of the trial show that the device can improve the quality of life of colorectal surgery patients, who can return to their normal activity shortly after treatment.
In providing a less-invasive alternative to diverting ostomy, Colovac fulfills SafeHeal’s promise of improving clinical outcomes and quality of life for colorectal patients.
Colovac will provide a local, temporary, less invasive protection of the anastomosis during the healing process:
- Timing : Colovac is designed to provide protection of the anastomosis during the critical initial 10-day anastomotic healing period.
- No ostomy : Colovac is designed to avoid the need for a diverting ostomy for the majority of patients who will not experience anastomotic complications.
- Possible reversal : Colovac is designed to allow for safe conversion to standard of care diverting ostomy for patients requiring extended anastomotic protection.
How it Works
Colovac provides protection of the anastomosis during the critical 10-day postoperative healing stage, giving the majority of patients the benefit of avoiding a diverting ostomy.
Colovac is comprised of a flexible bypass sheath that is anchored to the colon using a vacuum stent placed proximal to the anastomosis. The device is a minimally invasive, fully reversible internal bypass sheath that isolates the anastomosis from any contact with the fecal content during patients’ recovery, minimizing the sequelae of an anastomotic leakage (i.e. peritonitis).
Colovac Protection in 3 Steps
Colovac Protection in 3 Steps
Surgery is performed as standard of care: open, laparoscopic or robotic approach.
Colovac Placement: 5-15 min.
- Introducer insertion through the anus
- Placement of the Colovac device proximal to the anastomosis
- Connection to the vacuum system, enabling the vacuum seal and anchoring for 10 days after surgery
10 days after surgery
Colovac Retrieval: 5-15 min. Endoscopic retrieval procedure through the anus
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