Spectranetics (NSDQ:SPNC) said today it won CE Mark approval in the European Union for its AngioSculptX drug-coated PTCA scoring balloon catheter designed to treat coronary artery stenosis.
The device won indications for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restinosis, the Colorado Springs, Colo.-based company 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,” Bruno Scheller of Homburg, Germany’s Saarlandes University Clinic said in a press release.
The company said it will pay a $5 million milestone payment during the 3rd quarter, related to its receiving a CE Mark for the device.
“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,” CEO Scott Drake said in a prepared statement.
In February, Spectranetics said it won FDA 510(k) clearance for its Bridge occlusion balloon designed to temporarily occlude vessels during cardiac lead extraction procedures.
The company’s Bridge balloon is designed to reduce blood loss in the event of a tear and to provide a “bridge” to surgical intervention.
The post Spectranetics wins CE Mark for AngioSculptX drug-coated ‘scoring’ balloon appeared first on MassDevice.
from MassDevice http://ift.tt/2bgJgmk
Cap comentari:
Publica un comentari a l'entrada