These patients have a 50% risk of death at one year unless they are treated.

The US Food and Drug Administration (FDA) recently approved the CoreValve system due to its positive clinical performance in a US clinical study. It had low rates of common complications – such as stroke and valve leakage – which have a dramatic impact on patients’ quality of life.

With age, a heart valve can become stenotic, or narrowed, preventing it from properly opening and closing, which diminishes blood flow between the heart and the rest of the body. This causes the heart to weaken and function poorly; this condition is called aortic stenosis.

Symptoms include fatigue, dizziness, chest pain/pressure, shortness of breath during activity, heart palpitations and fainting. Approximately one-third of patients who suffer from severe aortic stenosis are not eligible for open-heart surgery because they are deemed at too high risk.

Morristown Medical Center was one of 45 US sites involved in the Extreme Risk Study of the CoreValve US pivotal trial, which led to the FDA approval of the CoreValve system.

Most commonly, the CoreValve system is inserted into a patient via an artery in the leg, and the physician then guides it through the arteries into the heart at the site of the original aortic valve. Once in place, it takes over the original valve’s function and ensures that oxygen-rich blood flows out of the heart efficiently and circulates throughout the body.

The advanced design of the new device was developed to address the needs of the transcatheter aortic valve replacement patient population, serving a broad spectrum of severe aortic stenosis patients.

The CoreValve system is suitable for patients with native valves of nearly all sizes, and it is delivered via a small delivery system, making it possible to treat patients with vascular systems that are small or difficult to navigate.

Additionally, the CoreValve system enables physicians to deliver the device to the diseased valve in a controlled manner, allowing for accurate placement.