Dive Brief:
- Abbott said Tuesday it won a breakthrough device designation for a fully implantable left ventricular assist device (LVAD), which could help speed the experimental technology through FDA review. The devices are intended for use in people with advanced heart failure who would otherwise need a heart transplant to pump blood from the heart to the rest of the body.
- The announcement comes after Medtronic said in October it received the special status for its own fully implantable LVAD, which would remove the need for a cable line to connect to an external power source like a battery pack or charging port.
- Abbott is using the acronym FILVAS (Fully Implantable Left Ventricular Assist System) to describe the experimental device, which, like Medtronic's version, is not yet available for sale anywhere in the world.
Dive Insight:
Since gaining St. Jude Medical's HeartMate product line in 2017, Abbott has been steadily building on its LVAD capabilities. Late 2018 saw HeartMate 3 gain FDA approval as a destination therapy, meaning it could be used permanently in advanced heart failure patients not eligible for a transplant.And last month, the company said FDA will allow its HeartMate 3 pumps to be implanted via a less invasive procedure called lateral thoracotomy.
In both cases, Medtronic's HeartWare systems has already achieved those standards. Today, Medtronic has a roughly three-month edge over Abbott on its breakthrough device timeline. But despite Medtronic's first mover advantage, Abbott has managed to take significant share in the overall heart failure market. Abbott's heart failure segment had organic growth of approximately 20% in 2019, with $769 million in total sales.
Separately, Abbott said Monday it received FDA's go ahead for a clinical trial comparing effectiveness of a left atrial appendage occluder to standard-of-care blood thinners in people with atrial fibrillation at risk of stroke.
