FDA clears transluminal coronary angioplasty perfusion balloon catheter
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Key takeaways:
- Teleflex’s percutaneous transluminal coronary angioplasty perfusion balloon catheter has received FDA 510(k) clearance.
- The device is indicated for dilation of coronary artery or coronary bypass graft stenoses.
Teleflex announced its percutaneous transluminal coronary angioplasty perfusion balloon catheter has received FDA 510(k) clearance for balloon dilatation of coronary artery or coronary bypass graft stenoses.
The perfusion balloon catheter (Ringer) is a rapid-exchange 0.014” compatible catheter with a helical balloon that, when inflated, approximates a hollow cylinder with a large central perfusion lumen allowing for continuous blood flow during prolonged inflations, according to a company press release.
In addition, the device’s large central perfusion lumen could serve as a delivery passage for use of secondary devices during percutaneous transluminal coronary angioplasty (PTCA), according to the release.
"The Ringer PTCA clinical study demonstrated that inflation of the Ringer [perfusion balloon catheter] for 60 seconds or more was well tolerated in the majority of patients who are vulnerable to procedural ischemia,” Kathleen Kearney, MD, principal investigator of the Ringer PTCA clinical study and interventional cardiologist at the University of Washington, said in the release. "We have been eagerly awaiting the arrival of the Ringer [perfusion balloon catheter] because of the potential its unique properties have to contribute to patient safety and evolve our practice in the most complex PTCA cases."
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