Intact Medical Gets Expanded 510(k) Clearance for Intact System
The FDA has granted expanded 510(k) clearance for the Intact System to preserve breast lesion architecture in samples of up to 30mm in diameter. The new indication allow physicians to remove intact lesions up to that size while preserving their structure for diagnosis, potentially resulting in fewer surgical procedures, Framingham, Mass.-based Intact Medical said Monday.
The minimally invasive procedure takes place in a doctor’s office and uses the Intact BLES system with Intact Excision XL wand to capture suspicious breast lesions in less than 20 seconds, the devicemaker said.
The process is superior to capturing multiple samples of tissue for analysis, which does not preserve architectural integrity, said President and CEO John Vacha. It also offers an alternative to open surgical excision, reducing patient discomfort, recovery time and costs, he added.
The Intact System was first cleared by the FDA in 2001. The Excision XL wand, cleared in 2008, was previously indicated to provide breast tissue samples for diagnosing breast abnormalities and for histologic examination with partial or complete removal of an imaged abnormality or palpable abnormality, company spokesman Eric Goldman said.
More than 75,000 Intact procedures have been performed in the U.S. and Europe, the company said. — Kellen Owings