Medtronic developing fully implanted LVAD with FDA breakthrough support

Dive Brief:

Medtronic received FDA’s breakthrough device designation for a new implantable heart pump it is developing to treat patients with advanced heart failure, the company announced Tuesday.
The left ventricular assist device (LVAD) in development would be fully implanted without a cable line extending to a power source outside the body. Current LVADs on the market, including Medtronic’s HeartWare system, rely on an external power source.
Medtronic said its early-stage device is not yet available for sale in any country.

Dive Insight:

Ventricular assist devices provide mechanical circulatory support to patients with weakened hearts, helping pump oxygenated blood from the left ventricle into the ascending aorta. The implant can be used as a bridge to a heart transplant or as destination therapy for patients who are not candidates for a transplant.

Medtronic’s main market competitor is Abbott, which acquired the HeartMate LVAD line in 2017 in its $25 billion deal for St. Jude Medical. Since releasing data showing improved survival and reduced adverse event rates for its HeartMate 3 system at a major medical meeting in March, Abbott has enjoyed a surge in sales in its heart failure business, posting year-over-year growth above 20% in each of the past three quarters.

Sales of Medtronic’s HeartWare system, meanwhile, have fallen dramatically. In the quarter ended July 26, Medtronic said LVADs posted a U.S. revenue percentage decline in the "low 60s" from the prior year while worldwide sales fell at a "high 40s" rate. The slump comes even as Medtronic touted favorable study results for the device in early July, indicating 95% of patients who got a HeartWare pump in a less-invasive thoracotomy procedure were free from disabling stroke after two years.

Now, Medtronic is moving in a new direction in pursuing an LVAD that would remove the need for a connection via cable to an outside power source. A Medtronic spokesperson said the company could not provide more details on the project because it is in the early stages of its development program. "But we are pleased that the FDA sees our development of a fully implantable LVAD system as a worthy technology to receive this breakthrough device designation," Tracy McNulty said in an email to MedTech Dive.

The company has characterized ventricular assist device therapy as an underutilized treatment, noting that of 240,000 eligible patients, less than 5% receive the technology.

Medtronic paid $1.1 billion for HeartWare International in 2016, adding the pump to its portfolio of cardiac devices that includes stents, pacemakers, defibrillators and heart valves. Before Abbott’s blockbuster St. Jude acquisition, the latter bought Thoratec for $3.4 billion in 2015 to gain HeartMate.

The breakthrough designation positions the company to receive additional input from FDA and accelerated review at the filing stage. Designated devices that later receive marketing authorization may also benefit from a CMS reimbursement model allowing products to receive payment even without initially demonstrating a substantial clinical improvement standard.