Mayo Clinic doctors published a study claiming that left ventricular assist devices can be used to treat restrictive cardiomyopathy, a heart condition affecting 500,000 Americans. This suggests the market for the blood pumps, which currently stands at about 6,500 implantations per year globally, has room to grow.
St. Jude Medical ($STJ) is betting that the LVAD market will grow quickly, with its $3.4 billion bid for Thoratec ($THOR), maker of the HeartMate II. The LVAD maker is currently fielding alternative offers during its 30-day "go-shop" period. Potential suitors are undoubtedly scouring studies like this one, as they try and gauge the market's growth potential.
"As a result of Mayo Clinic research, we now know we can improve clinical outcomes for patients with end-stage restrictive cardiomyopathy by using a left-ventricular assist device, which has become a standard therapeutic device for treating heart failure in dilated and ischemic cardiomyopathy. This is promising news, because patients with RCM have few therapeutic options and we continue to face donor shortages for transplant patients" said Dr. Sudhir Kushwaha, medical director of cardiac transplantation and mechanical circulatory support at the Mayo Clinic, in a news release.
The study consisted of 28 patients with end-stage heart failure who received an LVAD between 2008 and 2013. Mayo Clinic cardiologists recorded pre-operative data and post-operative events. Patients who eventually received a heart transplant and those using the device as a long term form of circulatory support demonstrated improved outcomes and fewer complications.
"While other studies have focused on risk factors associated with post-LVAD survival, this is the first study to focus exclusively on end-stage RCM patients and to identify the parameters associated with better outcomes," said the surgical director of Mayo Clinic's ventricular assist device program, Dr. Lyle Joyce, in the news release. "For example, we have defined criteria such as size of the left ventricle which is very important in determining outcome in these patients suggesting that with careful selection we can offer these patients a much better outcome and eventual cardiac transplantation."
The patients received either of the two devices on the market, Thoratec's HeartMate II or HeartWare's HVAD. The HVAD has won plaudits for its ease of implantation, but does not have the FDA's blessing to be used on long-term destination therapy patients, unlike the HeartMate II.
Both companies are designing next-generation devices that are supposed to be easier to implant using less invasive surgical techniques.