FDA approves MedicalCV's 1064nm wavelength laser technology for cardiac tissue

By Lisa Kerner

Erie, Pa., April 18 - MedicalCV, Inc. said it has received its third 510(k) clearance from the Food and Drug Administration for the MedicalCV Atrilaze Surgical Ablation system indicated for delivery of 810 nm or 1064 nm laser light to soft tissue to include cardiac tissue during surgical procedures.

This latest 510(k) clearance is for the 1064 nm wavelength laser technology, complementing the previously FDA-cleared 810 nm wavelength laser technology, according to a company news release.

"This most recent and strategic FDA clearance has broadened our laser technology spectrum with the inclusion of a 1064 nm wavelength," president and chief executive officer Marc P. Flores said in the release.

"With this wavelength, we are optimizing the application of laser energy to cardiac tissue. Furthermore, this wavelength is particularly suitable for the miniaturization required to utilize laser technology through smaller access ports, bringing us one significant step closer to delivering a truly stand-alone, minimally invasive procedure for the treatment of atrial fibrillation."

MedicalCV is a Minneapolis-based cardiovascular surgery company that develops products for the early treatment of cardiovascular disorders and disease.

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