Bracco Group’s Acist Medical Systems wins FDA nod for RXi Mini FFR

Acist Medical Systems said today that it’s launching its RXi Mini fractional flow reserve device after winning 510(k) clearance from the FDA last summer.

“Acist is excited about the additional value and flexibility that the RXi Mini will provide the cath lab,” president & CEO Brad Fox said in prepared remarks. “This next-generation FFR solution reflects our continued organizational commitment to providing technologies that simplify procedures and help physicians improve patient care.”

“Acist has raised the bar in making physiology accessible and easy to use in the cath lab setting,” added Dr. Michael Lim of St. Louis University, who performed the first procedure using the device. “FFR is the gold standard in diagnosing which lesions will most likely benefit from coronary interventions, including stent placement. The Acist Rapid FFR Mini RXi system makes it much simpler to perform FFR, whenever it is called for. With this advance, it continues to become easier to guide treatment decisions by invasive physiologic measurement – there really aren’t that many excuses left for the interventionalist to skip this step.”

The Eden Prairie, Minn.-based company said it plans to launch RXi Mini at the annual Transcatheter Cardiovascular Therapeutics conference in Denver Oct. 29-Nov. 2. The FDA granted 510(k) clearance for the device August 18.

Acist is owned by Bracco Group.

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