Abiomed (Danvers, Massachusetts) reported FDA approval of its premarket approval application (PMA) supplement for the AB Portable driver.

The approval allows the AB Portable driver to facilitate intra-facility patient transport, patient mobility for participation in physical and rehabilitation therapies, independent ambulation by the patient, and inter-hospital transport via aircraft or ambulance. According to Abiomed, the device offers a reliable cardiovascular support system, providing full Bi-Ventricular Assist Device (BiVAD) functionality. The new driver is designed to enhance the clinical use of the Abiomed AB5000 Ventricle by delivering direct benefits to both the hospital staff and patients by increasing mobility and versatility without compromising performance, the company said.

Specifically, Abiomed said the powerful, self-contained driver assists the sickest patients, offering hemodynamic support directly from the operating room up through the weaning process without additional computers or docking stations, which are required with current portable consoles.

Speaking to Medical Device Daily from the American College of Cardiology's (ACC; Washington) annual scientific sessions in Orlando, Aimee Maillett, an Abiomed spokeswoman, said the primary benefit of the AB Portable driver is that it provides up to 5,000 hours of continuous support.

A low-maintenance interval of 5,000 hours, or up to seven months of operation, is estimated to be three times longer than existing devices, according to Abiomed.

Maillett also noted that the patient's quality of life is improved with the new driver because it is much quieter and lighter than others on the market.

"Patients on full BiVAD support for heart recovery often require mobility and transport in order to provide a comprehensive assessment for a next stage of therapy," said Mark Anderson, MD, Department of Cardiothoracic Surgery, Robert Wood Johnson University Hospital (New Brunswick, New Jersey). "The AB Portable driver is lightweight and compact and the quietest portable Bi-VAD console on the market, yet still provides that full level of Bi-VAD support from the minute you leave the surgery suite."

At ACC this week, Maillet said the AB Portable driver is getting "some reaction," but she noted that it is the clinical staff that cares for the patient in the hospital, more so than the surgeon, that is most interested in the device. She said a lot of conference attendees have commented on how lightweight the device is.

According to Abiomed, the new AB Portable driver is 25% smaller and 15% lighter than current portable consoles on the market, allowing easier independent patient ambulation, in-hospital transfer or land/air transportation. The company also noted that the device is 50% quieter than current portable consoles on the market.

The AB Portable driver can operate up to 10 hours without recharging and includes an integrated battery-gauge display that offers the user real-time battery status displayed in hours and minutes, Abiomed said. The company added that the device is the only FDA approved portable console to provide that feature.

"The new AB Portable driver platform further strengthens Abiomed's portfolio for treating acute heart failure patients with profound cardiogenic shock, while allowing a greater degree of mobility and instant VAD support for the patient immediately after the procedure," said Michael Minogue, president/CEO and chairman of Abiomed.

Separate from the PMA supplement, Abiomed received conditional IDE approval from the FDA last May to conduct a U.S. patient discharge study with the AB Portable driver at 20 hospitals for 30 patients. The VOYAGER I clinical study aims to evaluate the safety and performance of the AB Portable driver system in combination with the AB5000 Ventricle in the outpatient environment. Of the 18 U.S. hospital sites that have submitted for IRB review, eight have received IRB approval and are open for enrollment in the VOYAGER I trial.

Maillett told MDD that the VOYAGER I trial would enable the AB Portable driver to allow patients to go on home discharge. "So that's really one of the exciting things we're looking forward to," Maillett said. That would improve the patient's quality of life even more, she added.

"This adds to our whole heart recovery continuum of care, being able to try to recover the heart as the first option rather than doing a transplant or bridge-to-transplant," Maillet said.