Heart-Assist Device Market Heats Up

MARKET ANALYSIS

Recent regulatory approvals and favorable reimbursement rulings are expected to provide a boost to the market for heart-assist devices. Such devices offer the promise of extending and enhancing the lives of 22 million people worldwide who suffer from heart failure, some of whom might eventually be candidates for a human heart transplant or an implanted heart-assist device.

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As the number of clinically viable human heart transplants continues to fall far short of demand, technological advances continue to show promise as permanent replacements for defective hearts. As a result, industry consensus is that the heart-assist device market could reach between $8 billion and $10 billion worldwide within the next few years. In fact, more than a dozen medtech manufacturers are actively developing products for what could be the next hot-growth sector for the worldwide cardiovascular market (see Table I).

Three heart-assist device manufacturers have recently received good news on the regulatory and reimbursement fronts. In June, Abiomed Inc. (Danvers, MA) received FDA approval for its Impella 2.5 micro heart pump. In May, the company gained reimbursement coverage from the Centers for Medicare and Medicaid Services (CMS; Baltimore) for its AbioCor self-contained artificial heart. At the same time, SynCardia Systems Inc. (Tucson, AZ) received CMS reimbursement for its CardioWest, a temporary total artificial heart. Meanwhile, Thoratec Corp. (Pleasanton, CA) received FDA approval for its HeartMate II device in late April.

AbioCor. The AbioCor, which is FDA approved under a humanitarian device exemption (HDE), is intended for severe chronic heart failure patients whose normal heart function cannot be restored, are not eligible for transplant, and, according to Abiomed, "have no other treatment options." Although AbioCor is considered to be an engineering marvel, it has a very limited market due to its relatively short life. Next-generation AbioCor II, which is in development, is 30% smaller than AbioCor I and is anticipated to have a life expectancy approaching five years.

Impella 2.5. Although little attention was given to the AbioCor announcement, FDA approval of Abiomed's Impella 2.5 device generated widespread interest from industry analysts. The device is billed by the company as "the world's smallest heart pump." Michael R. Minogue, Abiomed's chairman, CEO, and president, said, "The device seamlessly provides immediate, minimally invasive circulatory support for critical patients."

The Impella 2.5 is inserted into the left ventricle via a standard catheterization procedure through the femoral artery, into the ascending aorta, across the valve, and into the left ventricle. It pumps blood at a rate of 2.5 liters per minute. By contrast, intraaortic balloon pumps—the current standard of care—pump at a rate of 2.0 liters per minute.

Gregory Simpson, a medical device analyst with Stifel, Nicolaus & Co. Inc. (St. Louis), said Impella is "one of the most exciting products to hit the cardiology market in quite some time" and called the device "a game changer in the cardiac cath lab." Currently approved for up to six hours of use and primarily intended for high-risk angioplasties, Impella can also be used to stabilize a patient who has just experienced a heart attack, or for presurgery periods.

While other analysts recognized the potential of the new Abiomed micro pump, some expressed caution concerning the adoption of the new technology. They noted that the company will need compelling data to build the kind of mind-set among physicians that would result in a paradigm shift from the intraaortic pump to the Impella.

CardioWest. SynCardia cited CMS reimbursement of its Cardio­West temporary total artificial heart as the first of three benchmarks that it expects to achieve this year. With such benchmarks under its belt, the company expects use of the device to quadruple within the next 24 months.

The company's second benchmark will be its FDA application for approval of its Companion Driver system, which it will file later this year. Approval will enable stable Cardio­West recipients to recover at home while they await the availability of a heart transplant, a practice that has been in place in Europe since the device received the CE mark in July 2006. In the United States, Cardio­West is currently limited to hospital use.

The company's third stated benchmark would be worldwide availability of the Companion Driver system and ramped up production capabilities to meet the anticipated need.

Originally designed as a permanent replacement heart, the Cardio­West artificial heart is currently approved as a bridge-to-transplant for patients who are days, if not hours, from death due to end-stage biventricular failure. SynCardia reports that there have been more than 715 implants of the CardioWest device, accounting for more than 125 patient years of life on the artificial heart and a success rate of 79%. The company calls such results "the highest bridge-to-transplant rate for any heart device in the world."

HeartMate II. Thoratec describes the HeartMate II as a mechanical circulatory support device intended for a broad range of advanced-stage heart failure patients. An axial flow device, it can pump up to 10 liters of blood per minute, the full output of a healthy heart, and is designed to provide long-term cardiac support. The device is implanted alongside a patient's native heart and takes over the pumping ability of the weakened heart's left ventricle.

HeartMate II has only one moving part: a spinning rotor that runs continuously on bearings made of synthetic rubies lubricated by the steady flow of blood. The company reports the product features more-efficient lithium ion batteries, is easier to implant, and has a much longer life than earlier ventricular-assist devices (VADs).

HeartMate II is a 3.2-in.-long cylinder-shaped device that looks like an elongated D-cell battery. It weighs 12 oz and is intended as a replacement for the company's HeartMate XVE, which is 2 in. wide, 4 in. in diameter, and weighs 2.6 lb. The smaller size of HeartMate II is expected to extend its use to a broader range of smaller patients, including many women.

Suraj Kalia, medical technology analyst with SMH Capital (Houston), says HeartMate II is "a significant step-up over the HeartMate XVE, whose poor performance has stymied growth in the end-stage heart failure market." Kalia says Thoratec has a first-mover advantage and is ahead of its competitors not only in the bridge-to-transplant market, but also for the destination therapy market, where the company is positioned to potentially hit a home run.

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