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Intact Vascular Treating Peripheral Artery Disease Raises Money For New Trial


Posted in Implantable Devices by Arundhati Parmar on December 20, 2013

Intact Vascular aims to use the money partly to fund a new European trial to test its endovascular staping device to treat peripheral artery disease below the knee. 


The Tack-It Endovasular Staping Device Aims to Treat Peripheral Artery Disease in a less invasive manner

 

A Pennsylvania company that is evaluating a minimally invasive procedure to treat peripheral artery disease has secured additional financing of $4.69 million, according to a regulatory filing

Intact Vascular has developed the Tack-It Endovascular System, a stapling device, that is aimed at optimizing balloon angioplasty results in treating PAD.

The money will be used to fund a new European clinical trial that studies the device for PAD below the knee in patients with critical limb ischemia. These patients do not have good blood flow in the lower leg and foot.

The money will also help to prepare for a U.S. study, said Intact Vascular President & CEO Carol Burns, announcing the new European trial in a news release Tuesday.

In September 2012, the company announced that it had completed a Series A funding round in which it raised $15.5 million. Quaker Partners and H.I.G BioVentures jointly led the round in which angel investors also participated.

Earlier in 2012, the company received CE Mark to begin selling the system in Europe. The company believes that the Tack-It Endovascular System is superior to current methods of treating PAD for a number of reasons including the retaining of minimal foreign material in the leg artery following the procedure and allow “spot” treatment only where needed.

The device comprises a 4F multi-loaded catheter containing three self-expanding nitinol tacks.

“Stents, including balloon expandable, self-expandable, or even drug-eluting stents have not been successful in treating the arteries below the knee. Now, we are studying a smaller, less metal solution, and I believe physicians will like this for their patients,” said Dr. Marianne Brodmann, Medical University Hospital Graz in Austria, in a news release. “I like that I can treat only the segment in the artery where there is dissection.

Brodmann is the principal investigator in the European trial that will enrol 35 patients. 

 - By Arundhati Parmar, Senior Editor, MD+DI

arundhati.parmar@ubm.com

 


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