FDA approves new DES system for large, proximal vessels
Boston Scientific announced it received FDA approval for its drug-eluting stent system designed to treat large, proximal vessels.
The system (Synergy Megatron, Boston Scientific) is the only platform purpose-built for large, proximal vessels, the company stated in a press release.
According to the FDA premarket approval database, the new DES design approval included 3.5 mm to 5 mm sizes along with modifications to the expansion balloon and manifold. As Healio previously reported, the original version of the DES (Synergy) was approved by the FDA in 2015.
According to the announcement from Boston Scientific, the new DES system provides best-in-class radial and axial strength to maintain stent integrity; has the largest overexpansion range on the market; and is built with a platinum chromium alloy, making it visible on angiography and improving accuracy of stent placement.
Reference:
- FDA premarket approval database https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150003S054. Accessed on Jan. 25, 2021.