Thoratec Corp.’s continued rapid growth is driven by implants of HeartMate II left-ventricular assist device in heart failure patients ineligible for a transplant.

During its Feb. 5 fourth-quarter earnings call, Thoratec CFO Gerhard Burbach explained that LVAD implants in transplant-ineligible patients – known as destination therapy – continues to be the main revenue growth driver for the company in the U.S. He said that data from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) registry shows that destination therapy represents about 45 percent of all U.S. LVAD implants, up from 19 percent just prior to 2011, and about half of HeartMate II implants sold in the U.S. are for destination therapy.

“This strong growth highlights the success of our market development activities, including our referral initiatives within the larger cardiology community as well as our center development activities,” he said.

Burbach highlighted the company’s success in developing relationships with 70 smaller transplant programs and open-heart centers that adopted HeartMate II since 2009. Sales to this group now represent about 20 percent of HeartMate II sales in the U.S. and HeartMate II implant volume at these centers grew 30 percent, year over year, in the fourth quarter of 2012 and 50 percent for all of 2012.

The earnings report comes a little over two months after the launch of Thoratec’s first real competitor in the LVAD market – the HeartWare LVAD system from HeartWare International Inc.

“Looking forward, we anticipate that the DT indication will continue to drive growth across the spectrum of centers, but with an increasingly important contribution from smaller transplant and open heart centers,” he said.

The earnings report comes a little over two months after the launch of Thoratec’s first real competitor in the LVAD market – the HeartWare LVAD system from HeartWare International Inc. (See Also see "FDA Sticks Newly Approved HeartWare VAD With Unexpected Labeling Requirement" - Medtech Insight, 3 December, 2012..) Burbach acknowledged that his firm expects to lose market share as a result of the HeartWare launch, particularly in the bridge-to-transplant indication where the new product is approved. But he argues the loss will be offset by growth in the overall destination therapy market, which will remain primarily in Thoratec’s hands, at least for the near term. (See Also see "Thoratec Downplays Threats From Competing HeartWare Pump" - Medtech Insight, 6 August, 2012..)

Overall, sales of HeartMate II grew 23 percent worldwide to 3,858 units in 2012, including 21 percent growth in the U.S. and 30 percent outside the U.S., according to the company. Direct sales in Western Europe grew over 25 percent and sales through distributors in Europe and Asia grew 50 percent.

The HeartMate product line contributed $434.6 million to Thoratec’s 2012 revenues, an increase of 19 percent. The CentriMag line of extracorporeal blood pumps that the company obtained by acquiring Levitronix LLC in August 2011 contributed $35.7 million, an increase of 39 percent, year over year. (See Also see "Thoratec Expands Circulatory Support Biz With Levitronix Acquisition" - Medtech Insight, 8 August, 2011..) However, revenue from sales from the PVAD (paracorporeal ventricular assist device) and IVAD (implantable ventricular assist device) were down 33 percent to $19 million.

For all of 2012, Thoratec’s revenues were $491.7 million, an increase of 16 percent over revenues of $422.7 million for fiscal year 2011. Net income from continuing operations was $56.2 million.

In the fourth quarter of 2012, Thoratec’s revenues were $128.5 million, up 17 percent from the fourth-quarter of 2011. U.S. revenue was $102 million, up 16 percent year over year, while international revenue was up 25 percent to 26.5 million. In the fourth-quarter, the HeartMate product line contributed $110.8 million, an increase of 18 percent, the CentriMag line contributed $11.5 million, an increase of 31 percent, while PVAD and IVAD products contributed $5.6 million, a decrease of 8 percent.

Education And Support Efforts

The company plans to add approximately 15 new HeartMate II centers in the U.S. and 20 to 25 centers internationally, including about a dozen in Japan after the HeartMate II launches there at the end of the first quarter of 2013. The number of centers specifically certified for destination implants will grow from 118 now to over 125 worldwide by the end of 2013, according to Burbach. As of the end of 2012, there are 323 centers worldwide implanting HeartMate II, including 164 in the U.S. and 159 internationally.

The company support programs, branded Thoratec 360, are designed to help those centers improve efficiency and capacity to drive sales and differentiate Thoratec from its competitors, the CEO explained. For example, last summer, the company launched Thoratec Connect, an internet mechanical circulatory support program that helps implanting centers track Thoratec equipment and follow their patients’. So far, that program has been installed at 14 centers.

With the recent acquisition of the assets of CFK Cardiac Technologies, Thoratec has launched the Continuum “service platform” which manages the provision of drive line dressing supplies and replacement accessories for patients living with a HeartMate II. “These activities, including communication with the patient and his or her insurance provider, as well as billing the insurance provider, are time consuming and labor intensive, and Continuum provides VAD teams with a resource to outsource these responsibilities,” Burbach noted.

Thoratec’s market development team, which now includes more than 35 people, is focused on educating the referring cardiologists about the potential benefits of LVAD therapy to increase referrals to implanting surgeons. That team helped generate over 45 percent of all of the U.S. HeartMate II implants in 2012, and there were over 100 community cardiologists in 2012 who referred at least three patients who were implanted with an LVAD, compared to 70 in 2011, Burbach said. Also, a growing number of community cardiologists are managing LVAD patients, often supported by Thoratec’s Shared Care program, an initiative to help cardiologists and community hospitals help patients after they’ve received a HeartMate II.

“The goal of the program is to return patients to their referring physicians, thereby increasing their engagement in destination therapy patient care, [and] at the same time to increase implant center capacity by reducing the burden of follow-up care,” Burbach said. There about 50 sites currently participating in this program with all of the equipment needed to monitor patients after they leave the hospital. The company hopes to bring another 30 sites into the program by the end of 2013. “The Shared Care program has an important patient quality-of-life benefit, particularly for VAD patients located outside of metropolitan areas who might otherwise have to travel several hours to a major center to receive follow-up treatment,” he said.

The company is also expanding its patient outreach efforts with 200 “patient ambassadors” and a newmultimedia direct-to-consumer campaign which the company just began piloting in partnership with a leading VAD center. “Our goal with all of these programs is to raise the level of awareness of LVAD therapy as an important treatment option for advanced heart failure, empower patients and their caregivers, and to demonstrate the significant survival and quality of life improvements achievable with HeartMate II,” Burbach said.

The ongoing generation and dissemination of real-world data on the HeartMate II is also an important component of the Thoratec’s marketing strategy because it shows how the clinical and economic outcomes with HeartMate II are improving, Burbach said.

The company has enrolled nearly half of the planned 200 patients in ROADMAP, a post-market study of HeartMate II in heart failure patients classified as NYHA Class IIIB and Class IV patients INTERMACS profiles 4, 5 or 6. The NIH-co-sponsored REVIVE-IT pilot trial is randomizing ambulatory heart failure patients to HeartMate II or optimal medical management only. (See Also see "Thoratec Takes Over REVIVE-IT LVAD Trial From HeartWare" - Medtech Insight, 14 January, 2013..) He also mentioned that 102 out of a planned 200 patients are already enrolled in the TRACE study, evaluating anticoagulation or anti-platelet regimes in LVAD patients, and 206 out of a planned 400 patients are enrolled in the Driveline Silicone Skin Interface (SSI) registry which is evaluating driveline infections in HeartMate II patients.

Destination Therapy HeartMate II Implants Drives Thoratec’s Fast Growth

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