The U.S. Food and Drug Administration (FDA) recently granted a breakthrough device designation to a drug developed by Wayne-based Teleflex Inc., a medical technologies company.
The drug, Freesolve Resorbable Magnesium Scaffold (RMS), is for the treatment of percutaneous coronary intervention.
The designation is provided to device technologies that address unmet clinical needs and have shown that they have the potential to provide a more effective treatment for life-threatening diseases or irreversibly debilitating diseases or conditions.
“At Teleflex, we are advancing vascular intervention through strategic investment and continuous innovation,” Jason Fontana, Teleflex president and general manager of interventional, said. “This designation marks an important milestone in our efforts to bring Freesolve RMS to patients in the United States. 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. Freesolve RMS has the potential to redefine clinical practice in today’s cath labs.”
Freesolve RMS reduces the need for permanent implants and potentially offers an alternative to drug-coated balloons in cases where temporary scaffolding is required to support the vessel wall. RMS has demonstrated a 3.5 percent target lesion failure rate at four years.