LeMaitre Vascular Inc. (NSDQ:LMAT) won conditional approval from the Food & Drug Administration for a feasibility study of its TAArget thoracic stent graft it calls the Entrust trial.
The Burlington, Mass.-based vascular device maker first submitted its application for an investigational device exemption in May of last year for a study evaluating the safety of the graft, which the FDA deems a “significant risk” device. The agency granted conditional approval for the IDE Dec. 4.
LeMaitre “received conditional approval from the FDA to commence the ENTRUST Trial,” according to the filing, “provided that the Company resolves the issues identified in the conditional approval letter to the FDA’s satisfaction.”
Calls to LeMaitre seeking a more detailed explanation of the issues flagged by the FDA were not immediately returned.
If those issues are settled to the FDA’s satisfaction, the company said it plans to enroll 30 patients in the study, which aims to compare the TAArget device with open surgical thoracic aorta repair. The patients must be tracked for six months before LeMaitre can apply for an IDE supplement to conduct a pivotal study. If all goes well with that second trial, LeMaitre can then file for pre-market approval from the agency.
LeMaitre swung from red to black during the third quarter, posting substantial increases to both its bottom and top lines. The company posted record sales of $13.3 million during the three months ended Sept. 30, up 11 percent compared with $12 million during the same period last year.
And the bottom line swung from a $136,000 net loss during the year-ago quarter to net income of $1.3 million, prompting LeMaitre to raise its full-year sales and operating income guidance.