Blog Tag: Drug Eluting Stents
It has been a busy couple of months between Medtronic and the Food and Drug Administration (FDA), with Medtronic experiencing both recalls and approvals from the government agency. Below is a brief summary of some recent of Medtronic’s recent interactions with the FDA.
First, in early April, the FDA announced that Medtronic was notifying customers of a voluntary field corrective action for its Newport HT70 and HT70 Plus ventilators over the potential for unexpected shutdowns, which it believes are due to software issues in the devices. MassDevice reports that is recalling well over 7,000 of the affected devices.
Next, the FDA cautioned healthcare providers against using Medtronic’s NavLock Tracker with instruments not cleared to be used with the device. The NavLock Tracker is an accessory to Medtronic’s StealthStation navigation system for use during spinal fusions. As a result, Medtronic is updating its labels on the devices to indicate that only Medtronic instruments should be used.
In early May, Medtronic received official FDA approval for a new drug-eluting stent (DES) known as Resolute Onyx. According to FierceBiotech, the stent is formed from a single strand of a cobalt alloy wire with a platinum-iridium core and can provide physicians with stent sizes up to 4.5-mm and 5.0-mm. This newly approved stent is available for use in the United States, Europe, and countries that recognize the Conformité Européene (CE) mark.
In addition, Pat Shrader, Medtronic’s Vice President of Global Regulatory Affairs, appeared on Capital Hill to request changes in device manufacturing facility inspections by government officials due to the short notice that the manufacturing facilities receive prior to inspection. Shrader was speaking on behalf of the Advanced Medical Technology Association, which includes other companies such as 3M, St. Jude Medical, and Boston Scientific. Ms. Shrader called for standardization of inspections by the FDA.
Boston Scientific has prevailed in the appeal of its lawsuit against Cordis Corporation. Boston Scientific alleged in the lawsuit that Cordis’ 2.25 mm Cypher Sirolimus DES coronary stent infringed U.S. Pat. No. 5,922,021, entitled “Intravascular Stent”. Figure 1A from the ‘021 Patent is shown below:
In a per curiam decision, the Federal Circuit affirmed, without further comment, the District Court’s March 2012 decision, which awarded Boston Scientific enhanced damages based on a finding of willful infringement of the ‘021 patent. The total award to Boston Scientific was approximately $42 million. A 32% royalty rate was assessed on sales of Cypher stents not included in the judgment.
The ‘021 patent was previously subject to ex parte re-examination, and a re-examination certificate issued on April 17, 2012. According to a Cordis press release, Cordis discontinued manufacturing Cypher and Cypher Select Plus Sirolimus-Eluting Coronary Stents at the end of 2011.