Heart-Assist Device Market Heats Up 4800

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. According to the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH; Bethesda, MD), heart failure affects 5 million people in the United States, with 550,000 new cases each year, resulting in 300,000 deaths, and annual healthcare costs of more than $30 billion.

Market Potential

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).

Market Movers

Three heart-assist device manufacturers have recently received good news on the regulatory and reimbursement fronts. Earlier this month, 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.

Simpson anticipates that Impella will gain wider use as physicians experience the benefits of its quick and easy insertion and better pumping ability as compared to intraaortic balloon pumps. The company has two clinical trials under way that could result in the device demonstrating superiority to intraaortic balloon pumps and establishing Impella as a new standard in the cath lab.

Simpson expects the Impella 2.5 to “drive significant revenue growth for Abiomed going forward, and could ultimately result in the acquisition of the company by a larger player in the medical device industry.” However, noting the culture of caution among potential suitors, Simpson does not expect any moves in the near term. “Given the risk-averse nature of the industry's larger players, the big guys generally wait until the device is a certified success and then pay significantly more than what they could have bought it for earlier,” Simpson says.

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 mindset 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). Recipients can use shoulder-harnessed batteries for greater mobility up to several hours before replacement. A larger battery pack is required during sleep and extended travel.

Citing a “high level of enthusiasm for the device within the clinical community,” Gary F. Burbach, Thoratec's president and CEO, said, “The HeartMate II represents a new era in the treatment of advanced-stage heart failure with data demonstrating excellent survival rates, quality of life, and functional capacity for a broad range of patients.”

HeartMate II is a 3.2-in. long cylinder-shaped device that looks like an elongated D-cell battery. It weighs 12 ounces 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.

“HeartMate II is an important advance in mechanical heart technology,” said Daniel Schultz, MD, director of FDA's Center for Devices and Radiological Health. “Until now, some heart-transplant candidates have been underserved due to the large size of previously approved heart-assist devices.”

In recent clinical studies, Thoratec reported a survival rate of 77% after 12 months. As a condition of FDA approval, Thoratec must conduct a postmarket study with 169 HeartMate II recipients for up to one year.

Although currently approved as a bridge-to-transplant device, Thoratec intends to conduct clinical studies that will demonstrate the suitability of the implant as a more permanent replacement, or so called “destination therapy” device. Most analysts do not see such a milestone occurring until late in 2010.

Like most heart-assist devices, HeartMate II is not without potential problems. To avoid blood clots that can clog its turbine, patients are required to take a cocktail of blood thinners, and care must be taken with the cable to the battery pack, which can be a source of infection. Analysts typically describe these as minor issues that will likely be resolved as successive iterations of the device are introduced.

Thoratec's chief technology advisor, Victor Poirier, is generally credited with developing the first VAD in 1975, while working at Thermo Electron Corp., a company acquired by Thoratec in 2001. Poirier has been involved with the development of HeartMate assistive devices since the early 1990s.

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.

© 2008 Canon Communications LLC

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