Thoratec Corp. is counting on its future product pipeline, especially HeartMate III and HeartMate PHP, to drive revenue growth in its struggling flagship HeartMate ventricular assist device business.

On August 6, the company reported $118.1 million in revenue for the second quarter of 2014, a year-over-year drop of 9.5 percent, mostly due to declining sales of the HeartMate II VAD. The company shipped 863 HeartMate pumps worldwide, a decline of 16 percent year over year, including a 30 percent drop in unit sales outside the U.S.

Wells Fargo Analyst Larry Biegelsen said the worldwide left ventricular assist device market grew about 2 percent in the second quarter of 2014, down from about 19 percent in the first quarter 2014, so Thoratec apparently conceded about 1.4 percent of the VAD market to rival HeartWare International Inc. during the quarter.

The company now projects 2014 revenues will be $455 million to $470 million. At the end of the first quarter, Thoratec projected full-year revenues would be between $520 million and $535 million.

“It is now clear the impact is persisting longer than expected,” CEO Burbach said in reference to a 2013 NEJM study showing elevated rates of pump thrombosis with HeartMate II.

“We are clearly disappointed with this revenue performance and our guidance provision and are determined to successfully implement our plan to improve near-term results [but] we remain confident in the positive outlook for our core market and the HeartMate franchise,” CEO Gerald Burbach said. He pointed to “substantive recent progress with our product pipeline which continues to bolster our conviction in Thoratec’s opportunities ahead.”

NEJM Article Haunts HeartMate II

Burbach attributed some of the sales slow-down to the persisting impact of November 2013 report in The New England Journal of Medicine showing that some centers, at least, have experienced a growing rate of pump thrombosis in HeartMate II systems over the last few years. (See [A#01140210019].)

“We believe perceptions about pump thrombosis since the late 2013 New England Journal of Medicine article, along with greater scrutiny of clinical outcomes overall continues to be the largest factor impacting our business on a worldwide basis,” he said. “While we expected this would be a headwind during [the first half of 2014], it is now clear the impact is persisting longer than expected. Specifically, we believe some implanting clinicians have become more selective in their patient evaluation criteria. As a result, we believe the current conversion of referrals to implants within these centers may be trending lower than historical experience, while growth in overall referrals remains less robust than we planned despite our ongoing market development efforts.”

To combat the response to the report in NEJM, Thoratec has been talking-up “the broader and more favorable” HeartMate II clinical outcomes presented at the International Society for Heart and Lung Transplantation in San Diego in April, and educating customers on best practices for minimizing the risk of thrombus.

To validate these best practices, the company is about to start the PREVENT trial with 300 patients at 20 centers in the U.S. The primary outcome of the study is the incidence of confirmed pump thrombosis within three months of a HeartMate II implantation following Thoratec’s clinical management recommendations for reducing pump thrombosis.

The company also expects the next annual update from the INTERMACS registry of VADs will show that thrombus trends with HeartMate II have stabilized. The early results from the European arm of the TRACE study, to be presented at the EACTS conference in Milan in October, will show low thrombus and stroke rates in a multi-center experience with HeartMate II, the CEO said. Also, data from ROADMAP, a study comparing HeartMate II to medical therapy in New York Heart Association Class IIIB/IV heart failure patients, includes the three centers that contributed data to the report in the New England Journal and Burbach predicts that data, which will be available in early 2015, will show a low six-month thrombosis rate similar to the previously published INTERMACS data.

Pipeline Is Full

During the conference call, Burbach highlighted the progress of HeartMate III, a titanium continuous flow VAD with a magnetically levitated rotor designed to help reduce the risk of pump-related clots, bleeding and strokes. (See Also see "Thoretec Pipeline: HeartMate III Fully Magnetic LVAD Trial Set For 2012" - Medtech Insight, 31 January, 2011..)

The European HeartMate III trial has already enrolled 12 patients at five sites and enrollment has “proceeded at a quicker than anticipated pace,” Burbach said. The company projects the trial will complete enrollment of 50 patients by the end of 2014 and HeartMate III will earn a CE mark by the end of 2015.

Thoratec submitted an investigational device exemption to FDA in late June for a non-inferiority trial comparing HeartMate III to HeartMate II in both short-term bridge to transplant and long-term destination therapy patients. FDA recently granted conditional approval to start the initial safety phase of the study, so Thoratec is now on track to begin enrolling that trial “in the near future, ahead of our original schedule,” the CEO said.

Burbach also announced that the international trial of the HeartMate PHP (Percutaneous Heart Pump), a low-profile catheter-based implant for acute cardiac support, has begun in two sites in South America. (See Also see "Pressure Builds In Ventricular Assist Market" - Medtech Insight, 27 February, 2013..) The study will examine prophylactic cardiac support with HeartMate PHP in about 50 patients undergoing high-risk percutaneous coronary interventions. The company expects the study, which will also include sites in Europe, to support a CE Mark approval some time in 2015. So far, about 9 cases have been completed and “the device performed as designed and physician feedback was highly enthusiastic with regard to both use and performance,” Burbach said.

Thoratec expects to launch a U.S. trial of HeartMate PHP, examining urgent multi-day support in patients suffering from cardiogenic shock, by the end of 2014. FDA has provided positive feedback on the company’s proposed trial designs, so Burbach expects Thoratec to submit the IDE for the trial later in August. He added that Thoratec is also planning to test HeartMate PHP in a small group of cardiogenic shock patients outside the U.S. before starting the U.S. trial.

“Thoratec continues to believe that HeartMate PHP will offer clinicians a breakthrough technology for treating patients requiring acute hemodynamic support,” he said. HeartMate PHP will complement Thoratec’s CentriMag extracorporeal blood pump to give Thoratec a full line of acute circulatory support devices for surgery and percutaneous intervention patients.

Thoratec’s acquisition of Apica Cardiovascular Ltd., announced July 2, will give Thoratec access to technology it needs to develop a less-invasive VAD Surgical Implant System, Burbach said. (See Also see "Thoratec Seeks Less Invasive VAD Access With Apica Acquisition" - Medtech Insight, 3 July, 2014..) VADSIS is based on the proprietary coil and suture-less technology as Apica’s current transcatheter valve product.

Surgeons, especially in Europe, have been asking for a less-invasive approach to VAD implant, and the VADSIS is will enable both less invasive and off-pump (without cardiopulmonary bypass) VAD implants, he said. “VAD SIS represents the most effective and elegant approach available to address these important needs over time,” he said.

Thoratec expects to begin a clinical trial of VADSIS in Europe around the end of 2015. “The potential to further differentiate Thoratec technology in a meaningful way, as availability of the SIS product for use with our HeartMate product line should influence the competitive landscape,” Burbach said.

Thoratec Looks To Next-Generation LVADs To Revive Sinking Sales

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