Elegant Design for Better Healing

We’re giving surgeons a better device for preventing adhesions.

Imagine bands pulling and twisting your internal organs

Adhesions are unwanted bands that grow internally where they shouldn’t.

They cause pain, organ dysfunction, infertility and even death. They are a complication after most surgical procedures. Over 300 million surgical procedures are performed each year.

 

We looked at current methods of reducing adhesions

And saw that the grass was greener on the other side.
So we went there.

We developed a liquid surgical adhesion prevention device that works. A surgeon needs only 250 mL or less of the liquid, which is applied to the intraperitoneal cavity during an abdominal or pelvic laparoscopic or a laparotomy procedure. The liquid flows throughout the entire cavity and forms a protective barrier on all tissues throughout the cavity that prevents surgical adhesions from forming.

Watch the video.

We looked at current methods of reducing adhesions

And saw that the grass was greener on the other side.
So we went there.

We developed a liquid surgical adhesion prevention device that works. A surgeon needs only 250 mL or less of the liquid, which is applied to the intraperitoneal cavity during an abdominal or pelvic laparoscopic or a laparotomy procedure. The liquid flows throughout the entire cavity and forms a protective barrier on all tissues throughout the cavity that prevents surgical adhesions from forming.

Watch the video.

Safety

We are dedicated to making products that ensure safety for patients during and after their surgery.

We want patients to be home with family and friends as quickly as possible after surgery. To that end we devoted the time and resources needed for the most comprehensive adhesion barrier development and testing program to ensure the safety of our product.

Biocompatibility Tests

We passed more than a dozen different biocompatibility tests in accordance with internationally recognized biocompatibility standards, for example, ISO 10993, under Good Laboratory Practices (GLP) and/or Good Manufacturing Practices (GMP).

Why are we doing a volume escalation trial?

ARC is undertaking the first ever safety, volume escalation clinical trial of any anti-adhesion medical device to determine the highest safe volume for use in follow-on clinical efficacy research. This is a safer approach compared with that used for other adhesion reduction products that did not undergo a safety escalation clinical trial. ARC’s approach maximizes our chances of success in subsequent clinical efficacy studies.

This clinical trial complies with, and will be performed in compliance with:

  • The Declaration of Helsinki 2008
  • US standards of Good Clinical Practice (FDA Title 21 CFR part 812, Consolidated Guidelines, ICH E6)
  • The requirements and guidance provided in the most recent version of EU ISO 14155 and Health Canada Medical Device Regulations
  • Applicable local government regulations and Research Ethics Board policies and procedures, including the archiving of essential documents.

Efficacy 

The best response that can be attained; the ability to achieve an intended result.

We benchmarked our product against the best products on the market. Adhesions will occur in unpredictable areas throughout an entire surgical site. We are the only company with a liquid product that flows throughout, and then forms a film throughout, an entire surgical site and in this way prevents or reduces the formation of adhesions throughout the entire surgical site.

Efficacy

The best response that can be attained; the ability to achieve an intended result.

We benchmarked our product against the best products on the market. Adhesions will occur in unpredictable areas throughout an entire surgical site. We are the only company with a liquid product that flows throughout, and then forms a film throughout, an entire surgical site and in this way prevents or reduces the formation of adhesions throughout the entire surgical site.

ARC Medical Devices Inc. is an ISO 13485:2016 certified company | © 2020 ARC Medical Devices Inc.