Teleflex earns Breakthrough Device designation for Freesolve RMS

Teleflex has received FDA Breakthrough Device designation for its Freesolve RMS resorbable scaffold, according to MassDevice. The reported designation centers on Freesolve RMS, which uses magnesium alloy and bioabsorbable coating technology.

Designation reported for Freesolve RMS

MassDevice identifies Teleflex as the company receiving the designation and Freesolve RMS as the designated device. The publication describes Freesolve RMS as a resorbable scaffold.

The report places the regulatory update alongside the device’s materials approach. MassDevice says the Freesolve RMS uses magnesium alloy and bioabsorbable coating technology to provide vessel support during and after implantation.

Device profile in the report

The available report focuses on the scaffold’s vessel-support role and its use of magnesium alloy with a bioabsorbable coating. MassDevice describes that combination as part of the Freesolve RMS technology.

• Company: Teleflex
• Device: Freesolve RMS
• Reported regulatory event: FDA Breakthrough Device designation
• Technology cited by MassDevice: Magnesium alloy and bioabsorbable coating technology
• Reported role: Vessel support during and after implantation

What the update covers

MassDevice’s report is limited to the Breakthrough Device designation and the stated device description. It identifies the Freesolve RMS as a resorbable scaffold and notes its magnesium alloy and bioabsorbable coating technology.

For medical device sales professionals following regulatory developments, the event is a Teleflex designation update tied specifically to the Freesolve RMS. The source describes the device’s stated purpose as providing vessel support during and after implantation.

MassDevice reports no further details in the supplied item beyond the designation, the device name, and the described technology and vessel-support role.