Startup company Direct Flow Medical (Santa Rosa, CA) is taking on medtech goliath Medtronic, among others, in the transcatheter aortic valve replacement (TAVR) market, and it has a not-so-secret weapon: Polymer rings.
TAVR treats aortic stenosis, a narrowing of the space between the heart and aorta that can cause breathlessness, chest pain, fainting and palpitations and result in a decline of physical activity in the patient. Up to 1.5 million people in the United States suffer from the condition. Many in the medical community expect TAVR to become the standard of care for this condition in the future, writes Arundhati Parmar, Senior Editor at sister brand MD+DI.
Devices designed to treat TAVR typically have a metal frame in which the valve is housed. Direct Flow Medical replaced the metal cage with polymer rings, which provide two distinct benefits, CEO Dan Lemaitre told Parmar. "If you do look at the medical literature, competitive devices, especially the commercial ones, cannot achieve [the low level of paravalvular leak, or PVL, of the Direct Flow Medical device] and there's data out there that would suggest that if you can minimize or eradicate PVL, there is a higher survival rate in patients," said Lemaitre.
The low rate of PVL—when the blood flows backward into the left ventricle—reportedly is partly a byproduct of the polymer rings. The plastic construction also improves trackability, which refers to the ease with which the surgeon can implant the device. It can be repositioned, if needed, and is fully retrievable "if valve placement is not optimal," writes Parmar. The surgeon can remove the TAVR device and start over.
Read the full article in MD+DI: "Startup vs. TAVR Goliaths: A Tale of Polymer Against Metal."