Less than a year after debuting its Wirion embolic protection system, Cardiovascular Systems is recalling all of the devices manufactured and distributed between January and November 2021.
The Wirion system includes a filter inserted through a blood vessel in the leg via a catheter. The filter catches and removes any blood clots or debris floating in the bloodstream before they reach vital organs during an atherectomy procedure to remove plaque build-ups linked to peripheral artery disease.
In some cases, however, including when the filter basket becomes too full, the Wirion device may be difficult to withdraw using the retrieval catheter, potentially causing the filter to tear or separate from the catheter. If that happens, according to the FDA, it could require further medical procedures, allow a blood clot or other material to block the bloodstream, or lead to other serious complications, including death.
Because of that potential risk, the regulator has given Cardiovascular Systems’ recall a Class I rating, the FDA’s most serious category.
The Minnesota-based company initiated its voluntary recall of all unused Wirion devices in late November. At the time, Cardiovascular Systems had received nine complaints about the filter breaking during removal, with no deaths linked to the issue.
By the time the device maker reported the recall on Nov. 24, it had already contacted all affected healthcare facilities to ask that they stop using the embolic protection systems immediately and return them to Cardiovascular Systems.
In all, just under 700 of the devices were distributed in the U.S. between March and November of 2021, with manufacturing taking place between January and August.
The Wirion system received both FDA and CE mark clearance in March 2021, and Cardiovascular Systems announced that same month the first use of the device in the U.S.
In preparation for those regulatory submissions, the device was tested in the multicenter WISE LE clinical study. In the trial, use of the Wirion system led to a major adverse event rate of just 1.9%, which the company said is lower than those reported for other embolic protection filters. Additionally, the device resulted in no clinically significant instances of distal embolization during the study.
In the first full quarter following the launch of the device in March, Cardiovascular Systems saw a solid increase in revenues. In the fourth quarter of its fiscal year 2021, which ended June 30, it reported a nearly 70% bump in revenue, jumping to $71 million from the previous year’s $28.4 million take.