The Heart of the Matter

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SynCardia technology gives heart transplant candidates what they need most: hope

Once upon a time, Don Webber was a biomed major caught between his love for music and technology. The story you’re about to read isn’t a fairy tale, but the decision Webber made has led to miracle existences. “It was only upon reading about the very first implant of the Total Artificial Heart in December 1982 that I realized what I truly wanted to do. The first implant recipient, Barney Clark, made headline news every day as the world followed his progress, and I was riveted to it,” Webber said. “The technology and its potential to address the No. 1 leading cause of death, heart failure, inspired me to complete my degree and move on to advanced degrees in the sciences.”

Today, Webber is CEO of SynCardia Systems LLC, the developer and manufacturer of a revolutionary Temporary Artificial Heart (TAH) that enables patients with end-stage heart failure to survive comfortably while waiting for a permanent heart transplant.

“The device closely mimics what the human heart was intended to do — that is provide pulsatile blood flow to all parts of the body,” he told BOSS. “Because it immediately restores circulatory support to the pulmonary system and provides oxygen enriched blood to the organs it allows the patient time to recover and can increase the odds of a successful donor heart transplant when one becomes available.

In addition, patients can recover at home on the Freedom Portable Driver, which powers the SynCardia TAH, while waiting for a donor heart. “For TAH patients implanted following the rejection of a previously transplanted donor heart, patients are freed from the need for immunosuppressive drugs, allowing the body a rest period in preparation for a subsequent heart transplant.”

To the best of Webber’s knowledge, the TAH is the most expensive implant device on the market today. As such, keeping the costs in check so the system is attainable for all those in need is a big consideration in the unit’s design.

“From a practical perspective the barriers to entry in this market are enormous. First you need to solve the technology hurdles. Designing a device that is capable of pumping 65 million times a year for many years without failing is no easy feat. You then need to back the device with strong clinical evidence demonstrating both safety and efficacy. For a new competitor, this means your clinical data needs to be at least as good as ours, which frankly given the patient cohort we treat, is an incredible challenge in and of itself,” he explained.

Nearly 16 years after its initial US approval, the SynCardia TAH remains the only approved device of its kind on the market. “The biggest competitive challenge we face today is with the increased use of temporary devices (such as extracorporeal membrane oxygenation, intra-aortic balloon pumps, etc.) that are used for periods of time sometimes well beyond their approved intended use in hopes that a donor heart shows up before the patient decompensates.”

Webber revealed that recent data has emerged clearly showing that these other temporary devices are being used more than ever before and that, as a result, six-month post-transplant survival has decreased from 93% to 77% over the past year alone.

“You might be surprised how many excellent cardiologists, especially those at the referring regional hospitals, don’t even know the TAH is a viable treatment option for their advanced heart failure patients. There are centers still today that do not have this device as an option for their patients, which is very unfortunate. While the device is not intended for all advanced heart failure patients, for those that can benefit, it should at least be considered.”

To educate thought leaders and clinicians, the company partners with their Medical Advisory Board (MAB) to make sure that all heart failure cardiologists have the latest clinical data available to them and are trained on the use of SynCardia’s evidence-based treatment algorithms to inform patient selection and implant timing decisions.

Manufacturing a bridge to a brighter future

SynCardia performs all of its own device manufacturing and servicing as well as system design and development. However, they purchase most components from outside suppliers and utilize outside design firms’ expertise on some aspects of their design.

“The quality bar is very high for all SynCardia suppliers,” Webber stressed. “As we have had several patients use the implant for over four years, the parts our suppliers provide need to work flawlessly day-in and day-out for many years.

“Managing the supply chain can at times be very challenging. First, you have the day-to-day challenges associated with managing the ongoing manufacture of the currently approved devices. If a supplier changes anything in their process, or decides to obsolete a critical part from its inventory, we are required to not only qualify the change or part substitute but to also submit and gain approval of the change from each of our regulatory bodies globally before we can continue to sell the product. This is not only extremely costly but can sometimes take several years to complete, depending on the part and type of change it is. As such it is also just as important to understand the entire supply chain and the suppliers with whom our suppliers partner.

“The other issue medical device companies have to contend with is that by comparison to commodity devices like catheters, where thousands are manufactured daily, our annual volumes are measured in three digits. This can put off many suppliers who focus their business on mid- to high-volume customers. Occasionally, there is the potential challenge of a supplier refusing to sell their parts to a medical device company — especially one that uses the parts in a life support system. For some it is bragging rights to be part of our team; for others, the perceived liability risk exceeds the reward.”

SynCardia’s R&D group works very closely with members of their MAB and several customers when developing new products such as a next generation driver and a fully implantable system. “Listening to and incorporating their feedback into the design throughout the process is a crucial part of delivering a product that is well received upon regulatory approval.”

Giving the gift of more time is SynCardia’s mission, and for those patients enduring the agonizing wait for matching donor hearts the availability of a TAH isn’t just a fairy tale — it’s hope. That’s music to Don Webber’s ears, and ours as well.