News | Chronic Total Occlusion (CTO) | June 28, 2017

Philips Announces Relaunch of Pioneer Plus IVUS-Guided Catheter

Intravascular ultrasound helps physicians decide, guide, treat and confirm true lumen re-entry with speed and precision

Philips Announces Relaunch of Pioneer Plus IVUS-Guided Catheter

June 28, 2017 — Royal Philips recently announced the relaunch of its Pioneer Plus catheter, the first and 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 catheter is an invaluable medical device that benefits both physicians and patients,” said Thomas Davis, M.D., director of the cardiac catheter lab at St. John Hospital and Medical Center in Detroit.  “This catheter can decrease procedure time, which can potentially minimize the patients’ discomfort because they spend less time on the operating table.”

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 (CTOs), 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 CTOs patients are often at risk for amputation.

The device also provides a cross-sectional ultrasound image of the arterial area of interest to facilitate placement of guidewires beyond stenotic lesions (e.g., sub-total, total or chronic total occlusions) prior to additional interventions (i.e. PTA, stent, etc.). According to a study published by the Journal of Invasive Cardiology, the Pioneer Plus catheter demonstrated a 95-100 percent procedural success rate in procedures affecting the arterial wall, specifically subintimal angioplasty. The study found a rate of 26 percent of failed re-entry for cases of CTO that did not use the Pioneer Plus catheter.1

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.

Pioneer Plus has received U.S. Food and Drug Administration (FDA) clearance and CE mark approval. The device is not indicated for use in the coronary or cerebral vasculature. 

For more information: www.usa.philips.com/healthcare

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Angiography shows a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL lithoplasty.

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