Clinical Benefits

The Colovac Anastomosis Protection Device:

• Provides temporary protection of the colorectal anastomosis by diverting fecal contentthrough the sheath, reducing direct contact with the anastomosis while maintaining intestinal continuity and function.
• Potentially avoids the creation of a stoma (and avoids stoma-related complications) by postponing the decision to perform diverting stoma until anastomotic healing can be assessed and selectively reserves use of diverting stoma for only those patients with evidence of incomplete anastomotic healing.
• Potentially avoids the need for stoma reversal and related complications.
• Provides faster return to full digestive functionality.

Performance Characteristics

a. The Colovac Anastomosis Protection Device is designed to:

• Protect the Anastomotic Site:
• Isolates the anastomosis from fecal content via a flexible sheath and vacuum-sealed stent, thereby reducing contamination risk.

b. Enable Safe and Effective Use:

• Compatible with laparoscopic, robotic-assisted, and open surgeries, with placement and retrieval performed by trained healthcare professionals.
• Engineered from biocompatible materials, ensuring safety during the intended 12-day use.

c. Support Improved Patient Outcomes:

• Reduces the need for stoma creation and stoma-related complications by assessing healing before diverting stoma decision.
• Maintains intestinal continuity and function during the postoperative period

Contraindications

• Patient with active colitis.
• Known allergy to nickel or other components of the Colovac Device
• Pregnant or nursing female subject.
• Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel, carcinomatosis
• Currently, there is no clinical data collected on patients <18 years old.

Warnings

• Use of Colovac Device in a patient with any of the following serious or uncontrolled medical disorders that, in the opinion of the physician, may interfere with the patient’s health, has not been studied:
  • Immunodeficiency
  • Systemic steroid therapy
  • Severe malnutrition (>10% weight loss within the 3 months prior to the
    colorectal surgery)
  • Major surgical or interventional procedures within 30 days prior to the use of the Colovac Device or planned surgical or interventional procedures within 30 days post-Colovac Device placement.
• Carefully read all instructions prior to use. Observe all warnings and precautions noted throughout these instructions. Failure to do so may result in complications.
• There is a possibility of the need for surgical removal of the Colovac Device, in rare cases.
• Prior to use, the Colovac Device packaging and product should be inspected for signs of damage. Never use product that is damaged or from a damaged package as the sterility of the product could be compromised.
• The Colovac Device should be handled carefully. Prior to use, and when possible during the procedure, inspect the Colovac Device carefully for bends, kinks, non-uniform appearance, or other damage. Do not use a damaged device.
• The Colovac Device is intended for single use only. Do not reuse, re-sterilize or autoclave. Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness, or death of the patient. Cleaning, disinfection and sterilization may compromise essential material and design characteristics leading to device failure. The manufacturer will not be responsible for any direct, incidental, or consequential damage resulting from re-sterilization or reuse.
• Insertion of the Colovac Device should only be performed after the colorectal anastomosis is complete.
• Do not attempt to recapture/reload a device once it is placed.
• Do not attempt to reposition the device. Repositioning of the Colovac Device introduces a potential risk of creating a negative pressure that could lock the stent in place. If the clinician is not comfortable with the placement of the Colovac Device, the Device should be retrieved (refer to the instructions for Colovac Device retrieval). Once retrieved, a new Colovac Device may be inserted, or a conversion to stoma can be considered. If the second Colovac Device placement is still not satisfactory, conversion to stoma should be considered.
• Failure to disconnect the SmartVac prior to device retrieval may cause vacuum lock and possibly intussusception, which could lead to colon damage and/or necessitate surgical retrieval.

Basic UDI-DI

3770036318COL-01-EUHE

SmartVac

Intended Purpose

The SmartVac is intended to provide, monitor, and maintain vacuum to the Colovac Anastomosis Protection Device (Colovac Device). It is a single-use, non-sterile unit.

Indications for Use

The SmartVac is intended to provide, monitor and maintain vacuum to the Colovac Anastomosis Protection Device.

Intended Users

Clinical Benefits

Enhanced Anastomotic Protection:

• Supports the Colovac Device in protecting the anastomotic site from fecal contamination, aiding in improved healing outcomes.

Improved Patient Safety:

• Real-time alarms and monitoring minimize risks of device-related complications that could result from vacuum leaks or occlusions.

Reduced Stoma-Related Morbidity:

• The Colovac Device provides temporary protection of the anastomosis, potentially avoiding unnecessary stoma creation and its associated complications.

Optimized Postoperative Care:

• Designed for seamless integration into clinical workflows, enabling effective monitoring and timely action during the healing process.

Performance Characteristics

The SmartVac is designed to perform the following

Vacuum Maintenance:

• Delivers and maintains vacuum pressure within pre-defined parameters to support the functionality of the Colovac Device.
• Automatically compensates for vacuum fluctuations using an onboard pump.

Real Time Monitoring:

• Continuously monitors vacuum levels and detects deviations in vacuum pressure, providing auditory and visual alarms for conditions such as leaks, occlusions, a full fluid collection canister or low battery Operational Safety and Reliability:
• Designed for single-patient, multiple-use application to ensure device integrity and minimize the risk of contamination.
• Battery-powered operation with replaceable batteries supports continuous functionality.

Hygienic Waste Management:

• Equipped with a removable fluid collection canister to safely collect and contain bodily fluids for appropriate disposal

Contraindications

None known.

Warnings and Precautions

Basic UDI-DI

3770036318VMD-01-EURM