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Boston Scientific Launches Innovative Crossing Device to Treat Complete Blockages in Peripheral Arteries
Date:2/8/2012

length beyond 300 cm.

"The TruePath device is another example of innovation in our priority growth area targeting peripheral vascular disease, where a significant number of patients remain undiagnosed or untreated," said Jeff Mirviss, President of the Boston Scientific Peripheral Interventions Division.  "This innovative crossing device further expands our growing peripheral interventions portfolio and offers physicians an option to treat patients with challenging lesions in the lower extremities who may have otherwise faced amputation.  Addressing this growing health problem through the use of less-invasive devices could greatly improve patient care and ultimately save limbs."

The ReOpen clinical study evaluated the TruePath CTO Device in 85 patients with peripheral artery lesions.  Study results demonstrated the device is safe and effective in facilitating the crossing of intraluminal CTOs following resistance or prior failed attempts with a conventional guidewire.  In the study, technical success (defined as facilitation of CTO crossing) was achieved in 80.0 percent of patients, while improved post-procedure blood flow was demonstrated in 82.4 percent of patients.  Safety was demonstrated with a 98.8 percent freedom from clinical perforation at the time of procedure.

An estimated 17.6 million Americans and more than 30 million people worldwide suffer from peripheral vascular disease[1], which is characterized by blockages in vessels of the lower limbs and associated with high rates of morbidity and mortality.  CTOs are estimated to be present in approximately 40 percent of patients treated for symptomatic peripheral artery disease[2].

Boston Scientific acquired the TruePath technology through its acquisition of ReVascular Therapeutics, Inc. in February 2011.  The TruePath CTO Device has received 510(k) clearance from the U.S. Food and Drug Administration and carries CE Mark approval.

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