Abiomed implants first patient with long-term, removable heart pump

Abiomed has treated its first patient with its minimally invasive heart pump designed to serve as a “bridge-to-recovery” for people suffering from severe heart failure. 

The miniature device was implanted in the patient through an early feasibility study that the company plans to submit to the FDA. The device aims to help lighten the load on the cardiac muscle, allowing it to regain its strength for undergoing remodeling procedures or other treatments.

Less invasive than ventricular assist devices, which may replace portions of failing tissue and pump blood as the patient awaits a transplant, Abiomed’s Impella BTR is snaked into the heart’s chambers through the arteries. Once placed inside the left ventricle, a spinning impeller within the catheter pushes blood out to the body at a rate of more than six liters per minute.

“This novel technology could change the way we care for chronic heart failure patients by providing less invasive longer-term hemodynamic support with the goal of ultimately improving heart function in very sick patients,” said Jane Wilcox, M.D., chief of heart failure treatment and recovery at Northwestern Medicine Bluhm Cardiovascular Institute, who helped implant the device with Duc Thinh Pham, M.D., associate professor of cardiac surgery.

The company plans to ultimately enroll 10 patients at five hospitals in the clinical trial who will receive Impella BTR support for as long as a month during their hospital stay. After being digitally monitored 24/7 and showing signs of improvement, the patient will be weaned off the device and the implant will be removed. 

The study will examine the length of the participants’ hospital stays as well as changes in their quality of life after 90 days in addition to all-cause deaths and rates of cardiovascular complications. The ultimate goal of the device is to be able to send the patient home with the implant and provide up to one year of hemodynamic support.

Abiomed has received FDA approvals for similar heart pumps designed for patients undergoing surgery, such as procedures to reopen blocked coronary arteries as well as following a heart attack.

The company also obtained an agency clearance for its portable Breethe life support system, which exchanges oxygen for carbon dioxide in the blood to bypass a COVID-19 patient’s struggling heart and lungs, after receiving an emergency green light for its pumps in coronavirus-related heart failure.

Abiomed brought in $261 million in revenue during the final three months of 2021, the third quarter of the company’s fiscal calendar. That total represents a 13% increase over the same period the year before. It is scheduled to report its fourth-quarter earnings later this week.