Teleflex Announces FDA Breakthrough Device Designation for Freesolve™ Resorbable Magnesium Scaffold
Key Highlights
- ➤FDA grants Teleflex’s Freesolve RMS Breakthrough Device Designation for coronary intervention
- ➤BIOMAG-I study reports 3.5% target lesion failure at four years
- ➤99% of Freesolve RMS magnesium resorbed by 12 months
- ➤Ongoing BIOMAG-III trial supports potential future U.S. FDA Premarket Approval
- ➤Freesolve RMS remains investigational and not approved for U.S. sale
Expert Statements
David E. Kandzari, U.S. National Principal Investigator for the BIOMAG-III Pivotal Trial, Chief of Piedmont Heart Institute, and Chief Scientific Officer of Piedmont Healthcare
“Breakthrough Device Designation represents a significant milestone towards bringing Freesolve™ RMS technology to U.S. physicians and their patients.”
David E. Kandzari, U.S. National Principal Investigator for the BIOMAG-III Pivotal Trial, Chief of Piedmont Heart Institute, and Chief Scientific Officer of Piedmont Healthcare
“This designation recognizes the potential of resorbable scaffolds to address an important unmet clinical need in contemporary coronary intervention.”
Jason Fontana, President and General Manager of Interventional at Teleflex
“At Teleflex, we are advancing vascular intervention through strategic investment and continuous innovation,”
Jason Fontana, President and General Manager of Interventional at Teleflex
“This designation marks an important milestone in our efforts to bring Freesolve™ RMS to patients in the United States.”
Jason Fontana, President and General Manager of Interventional at Teleflex
“Building on the FDA’s previous Breakthrough Device Designation for Freesolve™ RMS in below-the-knee applications, it further underscores the potential of bioresorbable magnesium scaffold technology and our commitment to a leave-nothing-behind approach.”
Jason Fontana, President and General Manager of Interventional at Teleflex
“Freesolve™ RMS has the potential to redefine clinical practice in today’s cath labs.”
Teleflex Announces FDA Breakthrough Device Designation for Freesolve™ Resorbable Magnesium Scaffold
Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for its Freesolve™ Resorbable Magnesium Scaffold (RMS) for percutaneous coronary intervention (PCI).
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