Teleflex Announces FDA Breakthrough Device Designation for Freesolve™ Resorbable Magnesium Scaffold
Teleflex received FDA Breakthrough Device Designation for its Freesolve Resorbable Magnesium Scaffold for percutaneous coronary intervention. The designation should accelerate development and review, but U.S. approval still hinges on the ongoing BIOMAG-III pivotal trial supporting a future PMA application. Freesolve is already CE Marked and sold in Europe, Asia-Pacific, South America and the Middle East, and long-term BIOMAG-I data showed a 3.5% target lesion failure rate at four years.
Key figures
- Drug Name
- Freesolve Resorbable Magnesium Scaffold (RMS) / DREAM 3G RMS
- Phase Of Trial
- Pivotal trial (BIOMAG-III)
- Tlf rate 4yr
- 3.5%
- Magnesium resorbed 12mo
- 99%
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