Medical Device Daily Senior

It doesn't happen every day but once in a while a medical device is developed that ends up having benefits above and beyond what its maker originally intended it for. That seems to be the story for CorMatrix Cardiovascular (Marietta, Georgia), a company that develops extracellular matrix (ECM) biomaterial devices designed to harness the body's innate ability to repair damaged cardiovascular tissue.

CorMatrix reported Monday that Franciscan Alliance/St. Francis Heart Center (Indianapolis) is the first site to enroll a patient in the multi-center clinical trial of the CorMatrix ECM for pericardial closure to reduce the incidence of new onset postoperative atrial fibrillation (AF).

Beecher Lewis, the company's president/COO and co-founder, told Medical Device Daily that the goal of the study is to confirm the findings of a retrospective study of 222 patients published in October that suggest the technology reduces the relative risk of new onset postoperative AF by 54% compared to primary isolated coronary artery bypass grafting (CABG). The retrospective study was performed after doctors who used the CorMatrix ECM began noticing that the procedure appeared to reduce the patient's risk of new onset postoperative AF. It was a finding the company had not been searching for, Lewis said.

“We decided the logical progression was a retrospective study to see if their antidotal experience played out, and it did,“ he said.

The next step is to confirm the retrospective findings with a larger prospective randomized controlled trial. The new study will enroll more than 400 patients in up to 15 trial sites across the U.S., CorMatrix said. The trial is designed to assess the incidence of new onset postoperative atrial fibrillation AF in patients who undergo CABG and pericardial reconstruction using CorMatrix ECM, versus a control group of CABG patients for whom the pericardium will not be closed.

CorMatrix ECM, a naturally occurring bioscaffold, helps stimulate tissue growth by providing a location where the patient's cells can migrate and integrate with the ECM, eventually creating new tissue in place of the CorMatrix ECM.

“CorMatrix is excited to initiate this study of pericardial reconstruction and looks forward to future studies that will explore the many potential uses of the CorMatrix ECM technology,“ said Robert Matheny, MD, the company's chief scientific officer. “We hope this clinical trial will stimulate interest within the healthcare community on the unique advantages of ECM technology and the future of remodeling cardiac tissue.“

The retrospective study of 222 patients compared the incidence of new onset postoperative AF in primary isolated CABG patients who did and did not receive pericardial closure using CorMatrix ECM. Clinical outcomes of the 111 patients implanted with the CorMatrix ECM showed that new onset postoperative AF occurred in only 20 of 111 treated patients compared to 43 of 111 control patients, representing a 54% reduction in relative risk in the treatment group, the company noted.

“We've seen the significant results of the retrospective study published in Heart Surgery Forum and are encouraged by CorMatrix's commitment to pursue a prospective trial. We are excited to participate in this study because we believe reconstructing the pericardium with CorMatrix ECM will provide tremendous benefit to our patients,“ said Manesh Parikshak, MD, cardiothoracic surgeon at the Franciscan Alliance/St. Francis Heart Center, and co-investigator for the trial. “This is a particularly important trial given the clinical and economic implications of new onset postoperative AF, and we are pleased to have enrolled the first patient.“

Lewis told MDD that one of the company's biggest challenges is that its technology has so many different application possibilities and is therefor a platform technology. “If you are a valve company you have one widget, or one valve, that you're trying to develop and get through the regulatory commercialization process. Our challenge is that we don't have just one widget, we think we have a technology that may have applications into [several areas] I mean we're not trying to build one company we ultimately are going to be developing several companies,“ he said.

The CorMatrix ECM stands out from other technologies because regardless of what the application is or where it is being placed in the body “the material gets its signals and it gets its cues from what it's attached to“ Lewis said. The patient is not left with any foreign body that has a high risk of getting infected or calcified or simply being inside them forever, he added.

The properties of extracellular matrix biomaterials were discovered at Purdue University (West Lafayette, Indiana). The decellularized matrix material serves as a scaffold to allow adjacent tissues to deliver cells and nutrients to the matrix, which then differentiate into tissue-specific cells. The ECM material is gradually replaced, as the patient's own body reinforces and rebuilds the weakened site. During the repair, the matrix is naturally degraded and resorbed, leaving remodeled functional tissue where scar tissue or injured tissue would normally be expected.

According to the company, the use of extracellular matrix materials in non-cardiovascular applications has established a significant foothold in soft tissue repair, wound management and orthopedic applications. The safety of extracellular matrices has been well established in a number of different clinical applications, the company noted. Since 1999, an estimated 500,000 patients worldwide have received an extracellular matrix implant.

Last month the company reported winning $2.3 million in grants under the federal government's Qualifying Therapeutic Discovery Project program to advance the development of its ECM technology. The grant targets therapeutic discovery projects that show promise in developing new therapies to address areas of unmet medical need, or to treat chronic or acute diseases and conditions, potentially resulting in reduced healthcare costs. CorMatrix said it received the grant because of the potential of its ECM technology to improve cardiovascular disease treatment and outcomes.

Funds will be used for ongoing research into tissue regeneration, heart failure applications, drug-eluting ECM development, and to evaluate the CorMatrix ECM's potential in reducing new onset post-operative atrial fibrillation, the company noted (Medical Device Daily, Nov. 9, 2010).

Amanda Pedersen, 309-351-7774;