Patients with coronary artery disease may undergo a procedure called Percutaneous Coronary Intervention (PCI), commonly known as angioplasty or stenting. This minimally invasive heart procedure uses a small catheter to take pictures and deliver tools that are used to open or unblock arteries narrowed by plaque. The most common type of PCI is angioplasty, during which a tiny balloon is inflated to compress the plaque against the sides of the artery to help blood flow better. During a PCI, interruptions of coronary blood flow can cause problems, especially for patients with severe heart disease. As a result, patients with health risks such as diabetes, kidney disease, or anatomic issues with the heart may not be qualified for a conventional PCI. Now, a new stenting procedure may be an option for some patients with these additional health risks.

The new stenting procedure known as Protected PCI is designed to treat complex coronary artery disease and includes the use of the Impella heart pump from Abiomed, Inc. (Danvers, MA, USA). The use of an Impella heart pump during a PCI allows blood pressure and blood flow to be maintained during the procedure, which may allow surgeons to perform a more complete and optimized procedure. Impella is temporarily inserted through a small incision and advanced through the arteries and into the heart. Once in place, the Impella heart pump is turned on, pulling blood from the left ventricle and releasing it into the aorta. This active ‘unloading’ of the left ventricle increases blood flow to the brain and other vital organs and protects the kidneys from acute injury. When the heart is strong enough to pump on its own and the Impella heart pump is no longer needed, the cardiologist removes it before discharging the patient from the hospital.

Impella, the world’s smallest heart pump, is the only FDA-approved, non-surgical heart pump proven safe and effective to assist the pumping function of the heart during stent placement and ensure blood flow is maintained to critical organs. During a Protected PCI, or protected stenting procedure, the Impella heart pump is placed temporarily in the heart to assist the pumping function while the physician performs the necessary treatment (angioplasty, stent placement, etc.). Impella features SmartAssist technology that gives medical providers insights to help them improve patient outcomes through intelligent metrics. Impella, the world’s smallest heart pumps, are intended for temporary (less than or equal to six hours) use to maintain stable heart function.

Abiomed is now developing Impella Bridge-to-Recovery (BTR), a forward flow heart pump that is implanted via the axillary artery and sits in the left ventricle, can pump greater than six liters of blood per minute. It is smaller and less invasive than current LVADs and allows patients with chronic heart failure to have a longer-term minimally invasive heart pump option. Impella BTR’s design is intended to allow for heart recovery or heart remodeling with adjunctive therapies for patients with class III / IV heart failure. The vision of the Impella BTR development program is to provide a patient with home discharge and more than one year of full hemodynamic support. The first patient in the world has been successfully implanted with Impella BTR as part of the heart pump’s U.S. Food and Drug Administration (FDA) Early Feasibility Study (EFS).

“The first implant of Impella BTR is an important step toward our goal of improving patient care by providing a longer-term minimally invasive forward flow smart heart pump option with home discharge for patients with chronic heart failure,” said Michael Minogue, Abiomed’s Chairman, President and Chief Executive Officer. “Overall, Abiomed is creating the innovation for the field of heart recovery and solving a healthcare crisis for this patient population with advanced research and technology.” 

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