HeartWare technology is designed to provide a treatment option for patients waiting for a heart transplant who, otherwise, wouldn’t have any options. They are creators of the HeartWare® Ventricular Assist System, which received FDA approval in November 2012 as a bridge-to-transplant therapy for patients in the U.S. with advanced heart failure.
The HeartWare® System is comprised of three main components: the HVAD® pump, the controller and the battery pack. The pump sits inside the chest and is connected directly to the heart. It pulls blood from the left side of the heart and pumps it through a graft which is attached to the aorta, and then the blood exits the pump in a continuous stream – unlike the pulsing beat of a normal heart. The HVAD® pump is run by a small, external computer called a controller. The pump and the controller are connected by a small cable – called a driveline – that passes through the skin of the patient’s upper abdomen. The controller runs the pump and is powered by batteries and/or a direct AC/DC electrical connection. The complete HeartWare® System is portable and is carried in a case which may be worn around the waist or carried over the shoulder, allowing patients to take the system with them wherever they go.
Patients who receive a ventricular assist device have exhausted other medical treatments, and their only remaining option is a heart transplant. The number of patients awaiting a heart transplant far exceeds the number of organ donors. In the U.S., there are only about 4,000 heart transplants each year for the approximate 500,000 patients with advanced heart failure.
“At HeartWare, our mission is to create revolutionary technology for the treatment of heart failure to allow patients to get back to life,” said Godshall. “Our team strives every day to achieve this mission in what we call a patient-centric business culture. We are inspired by our patients, we are innovative in our approach to developing new technology, and we are principled in ensuring that our products are safe and effective.”
Today, HeartWare alone has implanted 5,000 HVADs in patients with heart failure around the world. Their device is used at 230 hospitals worldwide, including nearly 100 centers in the U.S. HeartWare has a global footprint consisting of 37 countries on 5 continents, and they’re entering new countries and regions each year.
In addition, HeartWare has a robust pipeline of heart assist devices in which they have been investing over the last few years. Among others is the MVAD®, a next-generation, miniaturized VAD which is approximately one-third the size of the HVAD® pump. The small size will enable support of smaller patients and those with right ventricular failure. In addition, the MVAD® may require less invasive surgery to implant than devices currently available. By reducing the invasiveness of the surgery, HeartWare hopes to treat a greater proportion of heart failure patients and to access patients at an earlier stage of their disease progression.
“Medical technology is advancing rapidly, as manufacturers are developing newer, smaller, less-invasive, next-generation devices that improve the quality of life for patients with heart failure,” said Godshall. “Though the VAD space is still relatively young, it has made significant developments from one generation of devices to the next, as device companies invest in newer technology and improve upon existing products.”
He added, “We have been fortunate to experience the level of growth that we have seen, and we hope that policymakers do not lose sight of the remarkable improvements our industry is making to benefit the lives of patients around the world and the lives of employees here in the U.S.”
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