Three former executives of a Colorado Springs medical equipment manufacturing company have been indicted for allegedly importing medical devices that had not been approved and cleared by the U.S. Food and Drug Administration.
As a result of the failure to be inspected by the FDA, the devices were deemed to be “adulterated and misbranded,” according to the U.S. Attorney’s Office in Denver.
The three former executives of Colorado Springs-based Spectranetics were identified as George John Schulte, 62, the former CEO of SPNC; Obinna Adhigije, 50, former SPNC vice president of business development, and Trung Pham, 37, former business development director at SPNC.
Spectranetics was a Colorado corporation that manufactured medical lasers and related devices, including catheters, that serve as intravenous sleeves that contain lasers.
According to the U.S. Attorney’s Office, doctors use the lasers to perform atherectomies – a procedure that removes plaque buildup from arteries or vein grafts.
The indictment alleges that from January 2004 through October 2008 the defendants conspired to bring the medical devices into the country without the devices being inspected, evaluated and cleared by the FDA.
The indictment also alleges that the defendants unlawfully promoted the medical devices for unauthorized uses. They allegedly concealed their actions not only from the FDA and the Department of Homeland Security but also from internal investigators at Spectranetics.
The U.S. Attorney’s Office said that Spectranetics has previously paid $5 million in a civil and criminal matter related to the case.
Howard Pankratz: 303-954-1939 or hpankratz@denverpost.com.
