Healthcare Industry News:  Patent foramen ovale 

Devices Interventional Cardiology Regenerative Medicine

 News Release - July 19, 2007

Bioresorbable Collagen Scaffold Placed inside the Heart Revolutionizes Treatment

Hole in Heart that May Cause Stroke and Migraines Closed

BOSTON--(HSMN NewsFeed)--BioSTAR(TM) (NMT Medical, Boston, MA), a device that incorporates a bioresorbable collagen scaffold used to treat Patent foramen ovale (PFO) has received regulatory approval in Canada and Europe. PFO is a common defect between the right and left atrium of the heart; essentially a hole in the heart that is usually asymptomatic. However, PFO may allow unfiltered blood and micro-emboli to pass directly into the arterial circulation and cause cerebral events, such as a stroke. BioSTAR(TM), which uses FortaFlex® technology created by ORGANOGENESIS, Inc., is designed to close PFO using the patient's natural healing response.

Stroke afflicts more than 750,000 Americans every year, and represents the third leading cause of death in the US. PFO has been directly linked to incidence of strokes, but recent studies suggest that there may even be a link between PFO and the development of certain migraines. These debilitating migranes affect approximately 28 million people in the US alone.

BioSTAR(TM) contains FortaFlex®, an innovative bioresorbable collagen scaffold that consists of highly purified and very strong sheets of collagen. FortaFlex® is a modular platform technology that can be custom bioengineered to meet the needs of a variety of surgical applications using a unique lamination and crosslinking process. The BioSTAR(TM) device incorporates the FortaFlex® bioresorbable collagen scaffold to function like a pair of small umbrellas. When the BioSTAR® device is deployed at the PFO, an umbrella of FortaFlex® sits on both the right and left atrium of the heart, effectively closing the hole between the heart chambers. 90-95% of the implant is absorbed over time and replaced with the patient's own tissue. Micro-emboli and unfiltered blood are therefore blocked from passing into the arterial circulation and thus averting a potential stroke.

BioSTAR(TM) and the FortaFlex® technology were used to close PFO in the UK-based, multi-center BEST (BioSTAR(TM) Evaluation STudy) clinical trial. At six months, 96% of the patients who received the device achieved complete PFO closure and no adverse events were reported.

Geoff MacKay, CEO of ORGANOGENESIS said, "What's exciting, is that this is reflective of the growing trend for biological materials like collagen to replace synthetic materials in many surgical procedures. Collagen is 25% of our total body protein; it is contained in skin, fascia, bones and teeth. Therefore, using collagen to repair and support parts of the human body makes perfect sense."

NMT Medical, the makers of BioSTAR(TM), chose FortaFlex® as the key component over other collagen biomaterials because of its inherent benefits.

FortaFlex® is:
  • Pure: undetectable amounts of DNA
  • Strong yet thin: the strongest biomaterial per unit thickness
  • Biocompatible: used in more than 5000 surgical procedures
  • Modular: able to be customized to provide optimal remodeling profile
  • Safe: BioSTAR has been used in cardiac applications without any adverse events
More information on the innovative FortaFlex platform is available on the ORGANOGENESIS website.


Massachusetts based ORGANOGENESIS, Inc. is the world's most successful regenerative medicine company and is focused in areas of wound healing, surgery and aesthetics. ORGANOGENESIS delivers living tissue "on demand" and its mission is to bring the medical marvel of regenerative medicine products to patients and to standardize its use in everyday medical care. More information about ORGANOGENESIS ( and FortaFlex® ( can be found on the web.


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