Philips has relaunched its Pioneer Plus catheter, which uses intravascular ultrasound guidance to help physicians with catheter placement when treating partially or fully blocked arteries, after a 2015 recall by the U.S. Food and Drug Administration.
The Class 2 recall stated that “due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the Pioneer Plus intravascular Ultrasound Guided Re-Entry Catheters.”
The recall was directed toward the Volcano Corporation, which Philips acquired earlier that year. The Pioneer Plus was originally released by Medtronic, and was acquired by Volcano in 2013.
Christopher Barys, senior vice president and business leader for image guided therapy at Philips Health Systems, said the company saw an opportunity to improve the overall design of the device, the first and only re-entry device on the market with intravascular ultrasound guidance.
“When we make devices here within Philips, patient safety and quality is No. 1,” Barys told HCB News.
Barys called the Pioneer Plus “one of our most exciting products within our portfolio.”
“It’s a critical element of improving patient care,” Barys said.
Using ultrasound at the tip of the catheter, the device helps guide interventional cardiologists when they are placing the needle through blockages and back into the true lumen. The company says it helps increase precision and speed during the procedure and has the potential to minimize complications.
“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., in a statement. “This catheter can decrease procedure time, which can potentially minimize the patients’ discomfort because they spend less time on the operating table.”
The company had its full market release of the product in May and it was welcomed back by physicians.
“Our customers were very frustrated not having this,” Barys said.
