Philips has announced the relaunch of the Pioneer Plus catheter, described as the only re-entry device with intravascular ultrasound (IVUS) capabilities and needle deployment designed to assist arterial vessel intervention.
IVUS captures images of vessels in the peripheral vascular system from inside the artery, allowing physicians to identify a targeted area and place a catheter in a specific location and to help guide the treatment partially or fully blocked arteries.
The Pioneer Plus IVUS-guided catheter helps physicians decide, guide, treat, and confirm true lumen re-entry with speed and precision, a press release from the company says. The device has received US FDA clearance and CE mark approval. It is not indicated for use in the coronary or cerebral vasculature.
The Pioneer Plus catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. Commonly used to help treat chronic total occlusions, which are caused by heavy build-up of plaque within an artery that can cause blockages, Pioneer Plus enables a physician to cross the occlusion beyond the stenotic lesion prior to additional interventional treatment of the lesion using interventional techniques. With a successful interventional procedure, patients may avoid having surgery, which is a considerable improvement in patient care and outcomes as chronic total occlusions patients are often at risk for amputation.
The Pioneer Plus catheter also provides a cross-sectional ultrasound image of the arterial area of interest to facilitate placement of guidewires beyond stenotic lesions (eg, subtotal, total or chronic total occlusions) prior to additional interventions. According to a study published by the Journal of Invasive Cardiology, the Pioneer Plus catheter demonstrated a 95% to 100% procedural success rate in procedures affecting the arterial wall, specifically subintimal angioplasty. The study found a rate of 26% of failed re-entry for cases of chronic total occlusion that did not use the Pioneer Plus catheter.
“Pioneer Plus is the only re-entry device that has intravascular ultrasound capabilities. The ultrasound on the tip of the catheter allows physicians to see inside the arterial walls to give them the information they need to properly assess the area of interest,” said Christopher Barys, business leader at Philips Volcano. “We are happy Pioneer Plus is back in our IVUS suite of products, which aim to deliver improved patient and economic outcomes.”
Philips initiated a design modification to the Pioneer Plus catheter in 2015, and proactively removed the device from the market until the modification was complete. The design modification has had no impact to the overall catheter dimensions, performance or the intended use of the device.