EU
Colovac1 is a colorectal anastomosis protection device intended to reduce the contact of fecal content at the anastomotic site following colorectal surgery. The device is placed at the time of the rectal resection surgery and is easily removed. Colovac is designed to remain in place for up to 12 days, until the body’s natural healing and tissue repair processes are complete, after which it is removed during an endoscopic procedure similar to a colonoscopy, without the need for a second surgical intervention.
Avoiding diverting stoma is a significant benefit for patients, surgeons, payors, and healthcare systems worldwide.
Colovac
The Colovac Anastomosis Protection Device is a sterile, single use disposable device. The Device consists of an Introducer pre-loaded with the Colovac Device. The Colovac Device consists of:
- An anchor consisting of a covered stent (Stent) delimiting an air- and water-tight volume (i.e. vacuum chamber) in which a vacuum is pulled upon delivery in the colon through two vacuum tubes
- A flexible cylindrical sheath attached to the anchor, covering the anastomosis, and with appropriate length so that it protrudes outside the patient’s anus (Sheath).
Note: The Colovac Device is designed to be used only with the Colovac SmartVac.
Colovac SmartVac
The Colovac SmartVac is battery powered and designed to maintain a vacuum accurately within a pre-set range to anchor the Colovac Anastomosis Protection Device in the colon. The SmartVac attaches directly to the Colovac Device using a Tubing Set that is supplied with the SmartVac. It supplies vacuum, continuously monitors the vacuum level and uses an onboard pump to maintain the vacuum pressure within the pre-set acceptable range.
Timing
Colovac is designed to provide protection of the anastomosis during the critical initial 10-day (-1, +2 days) 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 Conversion
Colovac is designed to allow for safe conversion to standard of care diverting ostomy for patients requiring extended anastomotic protection.
Clinical Benefits
Colovac is designed to address the #1 concern in colorectal surgery, which is protection of the healing anastomosis.
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, parastomal 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.
Colovac Clinical Experience
For more information on the Colovac and SmartVac devices, View essential safety and performance
How it Works
Colovac provides protection of the anastomosis during the critical 10-day post-operative 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, easily removable internal bypass sheath designed to isolate the anastomosis from any contact with the fecal content during post-operative recovery, minimizing the sequelae of an anastomotic leakage (i.e. peritonitis).
Colovac Protection in 4 Steps
Surgery is performed as standard of care: open, laparoscopic or robotic-assisted
laparoscopic colorectal surgery
STEP 1: Surgery
Lesion resection during open or laparoscopic surgery. Reconnection of the two bowel sections manually or using a surgical stapler.
STEP 2: Insertion
Colovac introducer insertion through the anus. Placement of the Colovac device proximal to the anastomosis.
STEP 3: Connection
Colovac connection to the vacuum system, enabling the vacuum seal, and anchoring for 10 days after surgery.
STEP 4: Retrieval
10 Days After Surgery
Endoscopic Colovac retrieval procedure through the anus.
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Intended Purpose
The Colovac Anastomosis Protection Device is intended for use in patients requiring low anterior rectal anastomoses to limit stoma creation to only those patients requiring more time for anastomosis healing when the device is removed, allowing patients with a healed anastomosis to avoid stoma creation.
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Indications for Use
The Colovac Anastomosis Protection Device is indicated for use following open, laparoscopic, or robotic-assisted laparoscopic colorectal surgery in patients indicated for diverting ostomy.
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Performance Characteristics
The Colovac Anastomosis Protection Device is designed to:
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- Protect the anastomotic site by isolating the anastomosis from fecal content via a flexible sheath and vacuum-sealed stent, promoting healing and reducing contamination risk.
- Enable safe and effective use compatible with laparoscopic, robotic-assisted, and open surgeries, with placement and retrieval performed by trained healthcare professionals.
- Support improved patient outcomes by reducing the need for stoma creation and stoma-related complications by assessing healing prior to a decision to perform diverting stoma.
- Maintain intestinal continuity and function during the postoperative period
- Incorporate only biocompatible materials, ensuring safety during the intended 12-day use.
1 Colovac and SmartVac are CE-marked per EU MDR 2017-745
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