CE Mark for Spectranetics AngioSculptX Drug-coated ‘Scoring’ Balloon

The Spectranetics Corporation has gained CE mark approval for its AngioSculptX Drug-coated PTCA Scoring Balloon Catheter.

Background

The Spectranetics Corporation develops, manufactures, markets and distributes medical devices used in minimally invasive procedures within the cardiovascular system. It claims its AngioSculptX is a first-of-its-kind device, combining the proven AngioSculpt PTCA scoring balloon catheter with a drug coating. It is indicated for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis. Reference to the term scoring means the device features nitinol “scoring” elements that create focal points to minimise slippage and aid in luminal expansion of stenotic arteries.

 Physician comments

“AngiosculptX represents a unique coronary scoring technology that incorporates a drug coating. Given its clinical results, it is a significant advancement in therapy options for patients,” said Professor Bruno Scheller of Saarlandes University Clinic in Homburg, Germany.

 Company comments

“Spectranetics is committed to providing specialized and innovative tools alongside compelling clinical data to improve our patients’ quality of life, and AngioSculptX exemplifies these important elements,” said President and CEO Scott Drake.

Source: Globe Newswire

 

 

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