Teleflex scoops FDA 510(k) clearance for interventional cardiology catheter

Teleflex has been granted 510(k) clearance on its Ringer Perfusion Balloon Catheter (PBC) for Percutaneous Transluminal Coronary Angioplasty (PTCA) procedures by the US Food and Drug Administration (FDA).

PTCA is a minimally invasive procedure undertaken to open blocked or stenosed coronary arteries to allow unobstructed blood flow to the myocardium. The company has stated Ringer will enter a limited US release phase this month.

When inflated, the Ringer PBC approximates a hollow cylinder with a large central perfusion lumen, allowing for continuous coronary blood flow during prolonged inflations.

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Indicated for coronary artery or coronary bypass graft stenoses, the Ringer assists physicians in situations where they require distal blood perfusion during balloon inflation to improve myocardial perfusion during PTCA procedures.

The lumen also serves as a delivery passage for secondary devices, a capability said to present new opportunities for procedural innovation during PTCA.

In a clinical study of the Ringer for PTCA, it was inflated for 60 seconds or more and found to be well tolerated in the majority of patients vulnerable to procedural ischaemia.

Kathleen Kearney, interventional cardiologist at the University of Washington and principal investigator of the clinical study for the Ringer PBC in PTCA, commented: “We have been eagerly awaiting the arrival of the Ringer PBC because of the potential its unique properties have to contribute to patient safety and evolve our practice in the most complex PTCA cases.”

“We listen carefully to the challenges that interventionalists face daily and are proud, once again, to introduce a solution for unmet needs with this revolutionary PTCA perfusion balloon,” said Teleflex medical director Christopher Buller.

According to GlobalData analysis, 61 PTCA balloon catheters are in various stages of active development.

As per GlobalData, the PTCA balloon catheter market was valued at around $1.64bn in 2023 and is projected to grow to a valuation of around $2.14bn at a CAGR of 2.8% by 2033.

GlobalData’s Market Size & Growth database projects that the overall interventional cardiology market will reach a valuation of around $33.47bn by 2033.

Elsewhere in cardiology, Restore Medical recently secured FDA breakthrough device designation for its ContraBand system to treat left ventricle failure.