Devices & Diagnostics

FDA clears more sizes of world’s only torqueable balloon catheter

A California medical device company announced Monday that the U.S. Food and Drug Administration has cleared more sizes of the world’s only torqueable balloon catheter used to treat complex percutaneous coronary interventions. TriReme Medical, based in Pleasanton, said the Glider PTCA balloon catheter is now approved for the treatment of coronary lesions in balloon diameters […]

A California medical device company announced Monday that the U.S. Food and Drug Administration has cleared more sizes of the world’s only torqueable balloon catheter used to treat complex percutaneous coronary interventions.

TriReme Medical, based in Pleasanton, said the Glider PTCA balloon catheter is now approved for the treatment of coronary lesions in balloon diameters from 1.5 millimeters to 3.5 millimeters and in lengths from 4 millimeters to 20 millimeters.

Previously, the balloon catheter’s safety and efficacy has been published in Euro Intervention, the official journal of Euro PCR, where it was found that the Glider balloon catheter was “particularly useful in rescue procedure where other balloon catheters fail to cross, especially in the setting of complex bifurcational interventions.”

TriReme describes Glider as the “world’s only torqueable angioplasty balloon catheter,” which is “designed to cross through tight lesions and stent struts even in conditions where other balloons are challenged.”

In a company news release, a physician in Arizona raved about the Glider.

“With its torqueable shaft and ultra-short 4 millimeter length, I am amazed that such a clever design can provide such powerful clinical benefits. Glider has become my go-to balloon when I approach the treatment of my most challenging cases,” said  Dr. David Rizik, medical director and interventional cardiologist at Scottsdale Heart Group.

TriReme Medical also has a base in Singapore and the company has been raising money since 2005 when it was founded. The latest financing round brought in $7.6 million, according to a regulatory filing.

[Photo Credit: Freedigitalphotos.net]

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