Abbott Continues to Show Heart with ‘Breakthrough’ Announcement

Abbott Laboratories continues to extend its list of milestones in the cardiovascular space. The Abbott Park, IL-based company has now won Breakthrough Device Designation from FDA for the in-development Fully Implantable Left Ventricular Assist System (FILVAS). FILVAS builds on the HeartMate 3 Left Ventricular Assist Device (LVAD). The technology was inherited by St. Jude Medical when it was acquired by Abbott. St. Jude inherited Heartmate 3 after it acquiredThoratec for $3.4 billion. Kevin Bourque, Divisional Vice President of Research & Development for Abbott’s Mechanical Circulatory Support portfolio laid out the key differences between FILVAS and the HeartMate LVAD. “People living with an LVAD today have to care for the site on his or her skin where the electrical power cable exits the body to make sure it doesn’t get infected,” Bourque told MD+DI “Additionally, people living with an LVAD also have to carry external batteries and a system controller everywhere they go. The only alternative is to be tethered to a cable plugged into the wall. Our HeartMate 3 system presently offers unprecedented benefits to patients in end-stage heart failure, but we don’t want to stop there. Having to continuously carry external equipment is a lifestyle disadvantage that everyone can appreciate. We are focused on continuing to drive such deterrents out of this life-saving techn...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Regulatory and Compliance Source Type: news