Medical Tubing and Extrusion

Medical tubing and extrusion technologies

Concept Medical

Concept Medical enrolls first patient in drug-coated balloon study

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Concept Medical announced today that it commenced the FDA investigational device exemption (IDE) study of its MagicTouch system. MagicTouch, a sirolimus drug-coated balloon (DCB), treats in-stent restenosis (ISR) in coronary artery disease (CAD). Dr. Said Ashraf enrolled the first patient in the MAGICAL-ISR study at the AtlantiCare Institute in … [Read more...] about Concept Medical enrolls first patient in drug-coated balloon study

Concept Medical wins FDA IDE for MagicTouch AVF drug-coated balloon

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Concept Medical today announced it received FDA investigational device exemption for its MagicTouch AVF Sirolimus drug-coated balloon (DCB) catheter. The IDE allows the Tampa, Florida-based company to start a clinical study to treat stenotic lesions of arteriovenous fistula (AVF) in the hemodialysis management of chronic renal failure. "This … [Read more...] about Concept Medical wins FDA IDE for MagicTouch AVF drug-coated balloon

Concept Medical lands FDA breakthrough nod for MagicTouch catheter

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Concept Medical this week said it received breakthrough device designation for its MagicTouch SCB sirolimus coated balloon catheter. The catheter is designed to treat small coronary artery lesions in coronary artery disease. The breakthrough device designation is indicated for percutaneous transluminal coronary angioplasty of small coronary … [Read more...] about Concept Medical lands FDA breakthrough nod for MagicTouch catheter