Cardiovascular Systems (CSI) and OrbusNeich Medical have announced premarket approval (PMA) from the US FDA for the Scoreflex scoring balloon.
OrbusNeich’s Scoreflex NC scoring percutaneous transluminal coronary angioplasty (PTCA) catheter (Scoreflex NC) is a focused force PTCA scoring balloon.
It features a dual-wire system that forms a focal stress pattern to enable safe and controlled plaque modification at lower resolution pressure.
Scoreflex NC is developed to dilate a de novo stenotic portion of a coronary artery and in-stent restenosis in patients evidencing coronary ischemia to enhance myocardial perfusion.
OrbusNeich chairman and CEO David Chien said: “We are extremely pleased to receive FDA PMA approval for our Scoreflex NC device and are delighted to introduce this scoring balloon to U.S. physicians through our distribution partner, CSI.
“In our continued commitment to delivering innovative products that can change the lives of many patients, we are confident our product will provide increased treatment options.”
In 12 US investigational sites, the Scoreflex NC – Scoring PTCA catheter clinical study was conducted with 200 patients.
The prospective, open label, multi-center, single arm and observational study was undertaken to assess the acute safety and device procedural success of the Scoreflex NC Scoring PTCA catheters in subjects with stenotic coronary arteries during percutaneous coronary intervention.
The trail’s data is said to support the acute safety and device success of the Scoreflex NC – Scoring PTCA catheter and its ability to use as a dilatation catheter in the stenotic portion of a coronary artery stenosis.
CSI chairman, president and CEO Scott Ward said: “We remain committed to expanding our portfolio of differentiated products that help physicians deliver improved outcomes for patients with complex coronary artery disease.
“Scoreflex NC complements our coronary orbital atherectomy system and expands the patient population we serve.”
In July 2018, CSI had entered into an exclusive international distribution agreement with OrbusNeich to market its coronary and peripheral Orbital Atherectomy Systems (OAS) outside the US and Japan.
