AngioSculptX has been developed to treat hemodynamically significant coronary artery stenosis, including in-stent restenosis.
The device combines the AngioSculpt PTCA scoring balloon catheter with a drug coating.
Spectranetics acquired AngioScore, which developed the AngioSculptX device, in 2014.
The company will pay $5m milestone payment to AngioScore related to receiving CE mark approval for AngioSculptX.
Germany’s Saarlandes University Clinic professor Bruno Scheller said: "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.”
Spectranetics president and CEO Scott Drake said: "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.”
Spectranetics is engaged in the development and marketing of medical devices used in minimally invasive procedures within the cardiovascular system.
Available in around 65 countries, the firm’s products are used to treat arterial blockages in the heart and legs, as well as to remove pacemaker and defibrillator leads.
The firm’s Stellarex drug-coated balloon peripheral angioplasty platform had secured CE mark approval in December 2014.
Its Lead Management (LM) product line features excimer laser sheaths, dilator sheaths, mechanical sheaths and accessories to remove pacemaker and defibrillator cardiac leads.
