AMSTERDAM, the Netherlands – Royal Philips (NYSE: PHG AEX: PHIA) today announced the relaunch of its innovative 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 Dr. Thomas Davis, director of the cardiac catheter lab at St. John Hospital and Medical Center in Detroit, Mich. “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 Pioneer Plus catheter 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 percent to 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
“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.”
Due to its strong commitment to quality and patient safety, 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.
The relaunch of Pioneer Plus strengthens Philips’ portfolio of peripheral interventional tools that are designed to help clinicians to effectively decide, guide, treat, and confirm the right form of treatment to deliver better care to their patients.
Pioneer Plus has received FDA clearance and CE mark approval. The Pioneer Plus catheter is not indicated for use in the coronary or cerebral vasculature.
1 Al-Ameri, H et al. Peripheral Chronic Total Occlusions Treated with Subintimal Angioplasty and a True Lumen Re-Entry Device. Journal of Invasive Cardiology. 2009; 21(9): 468-472.