Congestive heart failure is a condition when the heart has an imbalance in the pump function and fails to adequately maintain the circulation of blood into the body’s other organs.
There was a time when an individual with this cardiovascular disease had a choice to either wait for a heart transplant or hope that consistent medication can fend off an inevitable mortality.
But in the last ten years, incredible advances in medical technology such as implantable heart pumps or heart-assist devices have given patients a new hope to survive long enough to get a transplant or to survive without one. Unfortunately, the size of the heart pumps available in the market was limited to individuals with bigger torsos, thereby posing a hazardous implantation to patients with small frames, who are mostly women.
However, in April 21, 2008 the FDA Center for Devices and Radiological Health (CDRH) granted a premarket approval to Thoratec Corporation’s Heartmate II Left Ventricular Assist System (LVAS), a medical device smaller and lighter in weight by sixty percent than the existing heart pumps. Roberta C. Bogaev, M.D., the medical director of heart failure and cardiac transplantation at the Texas Heart Institute and a lead in the Heartmate II clinical trials describes how this device gives optimism to heart-transplant candidates that were previously under-served, “Historically, because of their size, such devices have been unavailable to women of small stature. Now that we have a pump about the size of a D battery, it will allow us to expand mechanical circulatory support options to more women.”
Developed from Thoratec Corporation’s thirty year experience in mechanical circulatory support, the Heartmate II LVAS is the newest heart-assisting device and currently the smallest and lightest heart pump in the market with only one moving part, thereby making it easier to implant than prior devices. It is composed of an axial flow pump implanted in the heart’s left ventricle, or the main pumping chamber, which can pump up to ten liters of blood per minute, the full output of a healthy heart. The pump is connected through the skin by a percutaneous cable that remains outside the body. This cable is attached to the external system controller which regulates the speed of the pump and connects to the power base unit and small monitor. If the patient wants mobility, they can also use a portable cable pack comprise of shoulder holsters and re-chargeable batteries.
Clinical trial patients of the Heartmate II LVAS have testified to an improvement in quality of life. Salina Gonzales, a mother and a teacher, was twenty-eight years old when she was diagnosed with congestive heart failure and was told she had a month to live. After three months on the Heartmate II LVAS, Salina was able to go back to school and teach her first grade students, and play with her son, “I just felt normal. There was nothing wrong with me. I didn’t feel any pain. I can walk really fast. I can sprint after my son in order to catch him. I can do anything again,” she said.
The Heartmate II LVAS is categorized by the FDA’s Part 800 Code of Federal Regulations (CFR) Medical Device Listing as a Cardiovascular Prosthetic Device, more specifically, a Ventricular bypass (assist) device under Section 870.3545. It is classified as a Class III medical device that must undergo Premarket Approval (PMA) before it is approved to be sold in the United States and must continue the most stringent FDA regulation in the Post market phase. Class III devices are considered ‘significant risk devices’, wherein the Heartmate II LVAS meets all its definitions because it is intended as an implant, used for supporting or sustaining human life, used to mitigate and treat a disease, and, in all circumstances, presented a potential risk to the health, safety, or welfare of a patient. FDA grants a PMA when the benefits outweigh the risks, and thus, the Heartmate II LVAS receives its approval based on a one-year follow-up data from one hundred ninety four clinical trial patients with severe heart failure, wherein eighty percent survived at six months and seventy-seven percent survived at one year.
Truly a milestone in cardiovascular device treatment, the Heartmate II LVAS provides congestive heart failure patients a new lease on life. But even more significant, this device is assessable to patients, such as women, who in the past could not have qualified for this kind of treatment. Twenty-seven year old Stacy Holford is a recipient. Her doctor, Todd Massey, M.D., the surgical director of the Strong Health Program says it best when he attests, “The HeartMate II has allowed us to provide her a bridge-to-transplant, so that her kidneys, lungs and liver work properly and she can stay alive until we are able to get her a new heart.”
References Used:  AHC Newsletters “Heartmate II leads the way in options for smaller bodies”, By Lynn Yofee and Don Long, July 8, 2008.  Medindia News “Heartmate II, Novel Compact Heart Pumps Eases Congestion for Women Awaiting Transplants”, Nov. 7, 2007  Cardiology Today “HeartMate II offers small size, applicability to more patients“, June 1, 2008  ABC News “Saved by the Beat of her Heart”, by Anna Wild, April 4, 2008  Title 21 – Food and Drugs, Subchapter H – Medical Devices, Cite: 21CFR870.3545  A Practical Guide to Food and Drug Regulation, Chapter 6: The Medical Device Approval Process, p. 131  Biology News Net “FDA Approves Heartmate II mechanical heart pump for heart failure patients”, May 2, 2008  University of Rochester Medical Center “Strong Memorial Implants its first Heartmate II”, August 3, 2004