FDA clears Ascent to reprocess bypass devices from Guidant and Medtronic
The FDA has cleared two Ascent Healthcare Solutions’ 510(k) submissions to reprocess specific Medtronic and Guidant cardiac stabilization and positioner devices.
The Medtronic models include the Octopus evolution tissue stabilizer, Starfish and Urchin heart positioners, and the Guidant models covered include the complete line of vacuum and mechanical systems: Xpose, Ultima and Acrobat systems.
The devices are mainly used in off-pump coronary artery bypass. Approximately 350,000 U.S. patients undergo coronary bypass grafts annually, and about 25 percent of those cases are being performed off-pump.
The Medtronic models include the Octopus evolution tissue stabilizer, Starfish and Urchin heart positioners, and the Guidant models covered include the complete line of vacuum and mechanical systems: Xpose, Ultima and Acrobat systems.
The devices are mainly used in off-pump coronary artery bypass. Approximately 350,000 U.S. patients undergo coronary bypass grafts annually, and about 25 percent of those cases are being performed off-pump.