Brian Buntz

September 10, 2014

5 Min Read
Will Artificial Hearts Be the Next Big Thing in Medtech?

It's too early to tell, but the total artificial heart might be the next potential medtech goldmine.

Shares of artificial heart maker Carmat climbed nearly 20% in mid-day trading on September 5 amidst recently-confirmed rumors that the company's technology had been successfully implanted in the second human patient.

If the technology ends up being suitable for a wide patient population and can be used as a long term fix for major heart problems, Carmat and other artificial heart makers would have access to a huge market. Roughly 600,000 people in the United States die from heart disease each year, accounting for one in four deaths, according to the CDC. Complicating matters is that heart transplants are in short supply, and can meet only a tiny fraction of patients with chronic terminal heart failure.

Carmat

Carmat's artificial heart now has been implanted in two patients.

Enter the total artificial heart, which could be widely available in a decade's time, according to a recent Motherboard article by journalist and futurist Zoltan Istvan.

Such a breakthrough would come none too soon for the medical device industry, which has had plenty of stumbles of late. The drug eluting stent was arguably the last blockbuster medical device the industry has come up with. It wasn't long ago that renal denervation was thought to be the next contender for that title, but now, many are speculating that the technology could be DOA. While the rumors of renal denervation's death may be exaggerated, the prospects of the technology have been severely limited after Medtronic failed to meet its efficacy endpoint in a pivotal clinical trial for the Symplicity renal denervation system.

Meanwhile, the number of artificial heart transplant surgeries is on the rise, Istvan notes, and more than 1000 artificial hearts have been used--albeit for short term use--in the past 35 years. In addition, more than 11,000 left-ventricular assist devices (LVADs) have been implanted. In 2010, former vice president Dick Cheney used such a device as a bridge technology before a heart transplant was made available. While originally envisioned as a bridge technology, LVADs have improved to the point that some patients are using them as a permanent treatment to help augment the work of a diseased heart.

Artificial hearts have been traditionally used for this purpose--to buy time while waiting for a traditional heart transplant. Carmat made news late last year after it announced the successful implantation of its artificial heart into a 76-year-old patient. Unfortunately, that recipient died 75 days later--likely because of a short circuit.

Now that it has implanted a second patient with an artificial heart, Carmat is optimistic that the technology could find broader use. The company had planned on applying for a CE Mark to market the technology in Europe by 2015.

While the notion of a fully functional artificial heart suited for long-term use sounds far fetched, research on the subject stretches back to 1956, when Willem Kolff, MD, PhD of the Cleveland Clinic created an artificial heart that kept an animal alive for 90 minutes. By 1981, Kolff had created an heart that kept a human patient alive for 112 days.

Time will tell whether Carmat or another firm will succeed in making the artificial heart a mainstream technology. Even if Carmat succeeds in proving the safety of the device, cost will be another concern. At present, its device costs in the ballpark of $200,000.

The aforementioned article by Zoltan Istvan considers this cost problem, but ultimately concludes, rather brashly, that "millions will electively line up for [the artificial heart] when it becomes available, even if they have healthy biological hearts," Istvan proclaims. "The benefits could be endless," he continues. "Have you ever been super nervous--such as on a first date, or while giving a public speech--and could feel your biological heart incessantly pounding? In the future, you'll just adjust your artificial heart to the right level for whatever context or experience you are in."

While the above analysis is more than a little speculative, the notion that artificial hearts could become a successful product in a decade or so is not.

Still, other researchers favor a more organic approach to replacing the heart. A 3-D printed heart could be a reality in a decade as well, according to Cardiovascular Innovation Institute's executive and scientific director. Stuart K. Williams, PhD. "We think we can do it in 10 years -- that we can build, from a patient's own cells, a total 'bioficial' heart," he explained in April.

Still other researchers are working on bioengineering working human hearts using hearts from human cadavers or porcine hearts, for instance, as a model. After harvesting the heart, researchers at the Massachusetts General Hospital are investigating the decelluarizing of a human heart from a recently deceased patient as a scaffold for a renovated heart built on a new cells matched to a target patient. (See video above.)

In any event, the mere notion that creating an artificial heart--either mechanically or 3-D printing could feasibly be developed within a decade's time point to the inevitability of seismic shifts in the medical device field. Even if innovators like Stuart Williams or Carmat fail, their ambition highlights the need to envision entirely new kinds of medical products and a solid strategy to get them on the market.

Refresh your medical device industry knowledge at MD&M Chicago, October 15-16, 2014, and MD&M Minneapolis, October 29-30, 2014.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.

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