BrosMed Announces Canadian Approval of RevoEdge™ High-Pressure Cutting Balloon
Release time:
2026-09-14
BrosMed Medical today announced Canadian regulatory approval of the RevoEdge™ High-Pressure Cutting Balloon Dilatation Catheter, expanding the company’s presence in North America and marking another milestone in the global commercialization of its specialty coronary portfolio.
IRVINE, Calif. and DONGGUAN, China — September 3, 2026 — BrosMed Medical today announced Canadian regulatory approval of the RevoEdge™ High-Pressure Cutting Balloon Dilatation Catheter, expanding the company’s presence in North America and marking another milestone in the global commercialization of its specialty coronary portfolio.
RevoEdge™ is a next-generation cutting balloon designed for the treatment of challenging coronary lesions, combining controlled plaque modification, high-pressure performance and deliverability. The device features one-piece molded nitinol cutting blades secured at both ends of the balloon without adhesive, providing an optimized balance of flexibility and cutting performance. Its controlled flexibility design enables the blades to re-wrap more tightly within the balloon folds, reducing the re-wrap profile and improving re-crossability.
The device also incorporates advanced double-layer non-compliant balloon platform, engineered to provide high-pressure performance while maintaining a low crossing profile. With a rated burst pressure of 20 atm, RevoEdge™ enables safe and effective high-pressure dilatation of high-resistance and heavily calcified lesions, providing controlled expansion with minimal balloon deformation.
“Canadian approval of RevoEdge is an important milestone for BrosMed and another step forward in our global commercialization strategy,” said Scott J. Addonizio, Chief Operating Officer of BrosMed. “We believe its combination of precision, high-pressure capability and deliverability provides interventional cardiologists with a differentiated option for lesion preparation.”
The approval strengthens BrosMed’s growing international regulatory footprint and supports the company’s strategy of bringing differentiated cardiovascular technologies to major global markets. BrosMed will now move forward with the commercial introduction of RevoEdge™ in Canada.
About RevoEdge™
RevoEdge™ is a high-pressure coronary cutting balloon dilatation catheter developed for lesion preparation in complex percutaneous coronary intervention (PCI). Its design combines molded nitinol cutting blades, advanced balloon technology and high-pressure capability to support controlled plaque modification while maintaining deliverability and crossability.
About BrosMed Medical
BrosMed Medical is a global medical technology company focused on developing and manufacturing innovative interventional cardiovascular devices. Its portfolio spans coronary and peripheral intervention, with technologies designed to address increasingly complex interventional procedures.
For more information, visit BrosMed Medical: https://global.brosmed.com/
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