Staff Writer

There are many things that can go wrong in the healthcare field, and those complications are usually more pronounced when it comes to a patient's heart.

One company is using its expertise in 3-D design software to develop a simulation model of the whole human heart. Dassault Systèmes (Waltham, Massachusetts) is also taking a leap into the healthcare sector with the "Living Heart Project," something that it traditionally hasn't been a part of.

"Historically the company hasn't been focused on lifesciences or healthcare," Steve Levine, senior director of product portfolio management for Dassault Systemes, told Medical Device Daily. "The company has a long history of producing 3-D technology and computer generated design and modeling tools for the aerospace industry. What we do is apply our understanding of the physics behind how a product would behave."

At the center of the Living Heart Project is a 3-D heart model powered by the Dassault Systèmes 3DEXPERIENCE platform's realistic simulation applications. Simulation experts working at Dassault Systèmes have used advancements in simulation to develop a 3-D heart model, capturing the electrical and mechanical behavior of the heart in what the company calls a vivid and realistic way.

The Living Heart Project has attracted a multidisciplinary community of medical researchers, practitioners, device manufacturers and industry regulators who will have access to 3-D computational models to accelerate the translation of research innovation into market-driven products and services.

"The next logical extension is to view things like medical devices," Levine said. "So if you want to look at a stent inside an artery, you can look at the fracture behavior or the interaction between the stent and the vein, artificial valves, pacemakers and things like that."

Firms could potentially use the models in clinical trials to see what impact the tested devices would have on the heart.

The company said this technology also has the potential to help medical professionals better understand the behavior of a patient's heart without the need for additional invasive diagnostic procedures.

Levine said that there were two reasons why the healthcare industry was migrating more and more toward 3-D models.

"I think there's recognition as they look toward their colleagues to some degree," he said. "Many of the people we're now meeting in the healthcare industry came from the aerospace industry. As those industries are about to mature and the tools are so mature they don't need that level of expertise, those people are actually finding themselves going into new fields where the frontier of the technology is. Healthcare is part of that next frontier."

He added, "There are some high profile issues that are driving it as well. For example, one that we're quite conscious of through our partnerships are pacemaker leads or defibrillator leads. There are a number of recalls with these devices that are pretty significant. There's a real need to figure out how to improve that."

The company said that it was hoping this realistic human heart simulation will not only become a valuable educational and translational tool to incite research innovation, but may also lead to accelerated regulatory approval cycles, reduced development costs for new and more personalized devices and will ultimately enable early diagnoses and improve treatment outcomes.

"We live in an exciting time with the capacity to simulate how a patient's heart may respond to a wide range of interventions, sparing that individual and many others the uncertainties of their procedural outcome," James Perry, professor of pediatrics at UC San Diego and director of electrophysiology and adult CHD at Rady Children's Hospital (San Diego), said in a release. "This is true for those with congenital heart defects, whose lives necessarily include many cardiac procedures, but also for the larger population of people with heart failure, arrhythmias and other structural abnormalities. This technology is a huge advancement that will expedite the translation of our basic scientific understanding of cardiac function into practical applications that promote improved health and safety. "

"The medical device companies have known this technology has been in various spaces," Levine said. "No one has ever done this in a way that many could use as a commercial product because the regulatory bodies would not accept some academic analysis. They needed something that has been validated, proven and reputable, so a commercial tool is really important in that context. For us we've been working with the FDA to then understand how they can establish a validation."

In the future, the technology could lend itself to other parts of the body.

"If you look a little further then there's no reason why we would imagine limiting ourselves to just cardiovascular issues," Levine said. "We think we can use this as kind of a template to show how communities can coalesce and really focus on stepping up the baseline of how these technologies actually can be used."

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