HeartWare International (NSDQ:HTWR) shares closed up 2.4% today after the company won a hearing date before the FDA’s circulatory system devices panel in April.
The sympathetic vibrations generated by the news also drove up shares of heart-pump rival Thoratec and Edwards Lifesciences , which is awaiting news of its own review by the panel for one of the PMA applications for its Sapien replacement heart valve.
The HVAD device is a left ventricular assist device, designed for end-stage heart disease patients who are waiting for a transplant – a so-called “bridge-to-transplant” therapy. The watchdog agency’s panel is slated to review the PMA application April 25, including data from the 140-patient Advance clinical trial, which the company ran from August 2008 to February 2010 under an investigational device exemption from the FDA’s Center for Devices & Radiological Health.
“Notification of the FDA advisory committee meeting represents continued progress toward our goal of obtaining U.S. approval of the HVAD system for patients with end-stage heart failure,” HeartWare president & CEO Doug Godshall said in prepared remarks. “We look forward to discussing the efficacy and safety data for the HVAD pump with the members of the panel and the FDA review team, and believe that these data underscore the potential utility of the HVAD system in improving treatment outcomes for end-stage heart failure patients.”
The panel is likely to take up a couple of issues that have bedeviled HeartWare, Leerink Swann analyst Danielle Antalffy wrote today. A year ago, a Wisconsin hospital suspended clinical trials of the HVAD after a patient implanted with the device developed a blood clot that caused it to malfunction. The reviewers are also likely to home in on the Advance trial’s first-ever use of a registry as a comparator, according to Antalffy.
“Though the panel could be contentious, we continue to believe the HVAD will be recommended for approval and ultimately approved based on strong survival data, now at 93% in most-recently published data, and low rates of adverse events like GI bleeding and infection,” she wrote. “To us, the higher rate of thrombus – 9.2% in the initial Advance + Continued Access Protocol cohort presented at ISHLT in April – is manageable.”
That’s because the company has altered the device’s specs to reduce the potential for mechanically-created blood clots and changed the protocols for the study to make clotting less likely, Antalffy noted.
Since mid-March, “HTWR has presented incremental – albeit small – sets of data that show a positive trend with thrombus declining to 5.4% at the EACTS meeting in October,” she wrote.
HeartWare is hustling to catch up with Thoratec, which is already ensconced in the U.S. LVAD market. Its HeartMate II device won a PMA as a destination therapy in September 2010, meaning it can be used in patients who are too sick to undergo a transplant or other surgical intervention.
But Thoratec has already baked a mid-year approval timeline for its competitor into its guidance for the year, making its forecast a conservative one, according to Barclays Capital analyst Matt Taylor.
“Net-net, we now view THOR’s guidance as conservative, though we think the April panel removes the bull case of a more extreme HTWR delay,” Taylor wrote today in a note to investors.
For Edwards, the HeartWare panel date could mean more clarity on the timeline for its PMA application for the Sapien transcatheter aortic valve implant for patients with operable severe aortic stenosis.
“Prior to today’s announcement (as recently as Friday), we believed that the only date on the calendar in 2012 for a circulatory system devices panel was 5/23. As of this morning, there are now dates of April 25-26 as well,” Taylor wrote. “Given the 2-day panel and HTWR’s 4/25 date, we think this could mean that EW gets either a 4/26 or 5/23 date (though we do not rule out the possibility of another date).”
HTWR shares closed up 2.4% at $71.55 apiece today on Wall Street, where investors also bid up THOR shares to $34.76 each, a 1.3% gain on the day. EW shares closed at $73.93, down .27%.