W.L. Gore & Associates, Inc. has continued to evolve their products by keeping patient outcomes and cost concerns at the forefront of their innovation plans. In support of those efforts the company recently unveiled the new GORE SYNECOR portfolio of intraperitoneal and preperitoneal repair devices, which they say will change the field of hernioplasty.
Surgeons are always attentive to developments in the healthcare field, looking for the next advance that will make life better for their patients. That quest for improvement has arguably been heightened in recent years for those who specialize in hernia repair procedures, especially in the area of surgical mesh.
Gore has been engaged in the hunt for a better set of solutions. They think they may have found it with the company’s portfolio of GORE SYNECOR Biomaterial products, which are hybrid, biosynethic hernia repair devices. The portfolio includes the GORE SYNECOR Intraperitoneal Biomaterial and the GORE SYNECOR Preperitoneal Biomaterial, which recently received FDA clearance.
In creating the materials that compose these devices, the manufacturer looked to previous synthetic and biological meshes, pulling together the best characteristics from each approach. In setting goals for the new product, Gore prioritized strength, endurance, and patient comfort.
“Specifically, the hybrid device joins the absorbable, clinically proven GORE BIO-A Tissue Reinforcement with conformable polytetrafluoroethylene — or PTFE — an inert material that will not degrade,” says David Lane, business leader of general medical products at Gore. “There is no compromise in strength even as the biodegradable GORE BIO-A Web generates appropriate tissue integration and vascularity.”
That information can be difficult to parse. For surgeons, the bottom line is a little simpler: the SYNECOR Biomaterials should provide a new, improved option for patients at heightened risk for post-op complications following hernioplasty.
And the substance itself should feel somewhat familiar to practitioners.
“It’s similar to hernia meshes in general,” notes Bruce Ramshaw, MD, FACS, chair and professor of surgery at University of Tennessee at Knoxville, University of Tennessee Medical Center. “It is somewhat of an improvement because it’s got some more memory to it. Especially when used laparoscopically, it has a little easier handling.”
Ramshaw has been working with Gore on a novel clinical quality improvement (CQI) study evaluating the real-world use of GORE SYNECOR Intraperitoneal Biomaterial in patients. He says they’ve brought an expanded scope to their efforts.
“These traditional clinical research methods are based on the reduction of science platforms,” Ramshaw explains. “We started a clinical quality improvement platform for SYNECOR that’s based in systems or data science. So those methods are much more flexible, they include all patients — no inclusion or exclusion criteria — and the goal is to measure outcomes better and learn how to improve outcomes at every local site where the project is being done.”
The methodology allows Ramshaw and his colleagues to drill deeply into the data, developing site-specific analytics based on variables unique to differing healthcare environments. Thus far, there have been no mesh-related complications observed in over 200 patients that have undergone hernia repair with the GORE SYNECOR Intraperitoneal device. According to Ramshaw, any anomalies that have arisen were attributable to complications unrelated to the mesh, such as troubles with incision healing and other commonplace issues.
While the long-term health of patients is obviously the top concern in the study, the research has also lent analytical resources to understanding the fiscal outcomes related to use of the device. Counting pennies hasn’t always been part of medical research, but the current reality of the field is changing that.
“We’re recognizing that the model for healthcare that’s built around doing services — being paid for each service and driven by volume — is not a sustainable model, and so the transition to a value based healthcare system is more and more recognized as a need,” Ramshaw says. “But there’s a very significant lack of an understanding of how to do that. It really requires the measurement of value in the context of a definable patient care process, and it should be done at every local environment.”
Ramshaw says that approach is being taken with the SYNECOR Biomaterial research, even though it’s challenging.
“It’s not easy to do, because of how our system is structured today, but it’s going to be absolutely essential for the future,” he says. “One of the basic principles of systems science and data science is: If you’re not able to measure it, you can’t improve it. And we’ve demonstrated that over and over again in healthcare. We’re not measuring the value of care we’re providing and we’re clearly not improving it the way our current system is structured.”
The more this all-encompassing approach to research is employed across the healthcare landscape, the easier it will be to fix the significant and interrelated problems.
“If we can restructure our patient care to understand how to measure the value of care and use data and analytics to drive costs down and improve outcomes, then we can transition into a sustainable healthcare system,” says Ramshaw.
Thinking about how care efficacy and cost consideration need to intersect has helped Gore create a portfolio of products that serves both needs.
“In ventral hernia repair, the era when hospitals and other centers were primarily focused on
case volume has passed,” notes Lane. “We are seeing reimbursement increasingly based on episodes of care to capture the true costs of achieving a specific outcome. The acquisition cost of GORE SYNECOR Biomaterial can be less than half of some commonly used biologic meshes and can be used in place of biologic, permanent, synthetic meshes, and other biosynthetics.”
Over the years, hernia repair surgery has seen major changes in approach. With GORE SYNECOR, W.L. Gore & Associates believe they may have brought forward the next crucial innovation.