Conditional IDE Approval For CryoLife’s PerClot® Hemostat U.S. Study

CryoLife, Inc. has received conditional approval of its Investigational Device Exemption (IDE) for PerClot from the US FDA. PerClot is an absorbable polysaccharide hemostat, intended for adjunctive use in surgical procedures when control of capillary, venular, and arteriolar bleeding by pressure, ligature, and other conventional means is ineffective or impractical.

CE Mark For Laparoscopic Surgery Safer Access Device

Interesting concept this. The Lifecare Keyhole Cup is a clear plastic dome that sucks in the anterior abdominal wall following application of negative pressure. This in turn separates the wall from the underlying tissues and provides a safe environment in which to insert the Veress needle prior to laparoscopic surgery. The cup is then removed.

FDA Clears Microline’s Flexible Ligating Shears

Reposable instrument company Microline Surgical, Inc.,has received FDA 510(k) clearance for its MIS Flexible Ligating Shears, enabling surgeons to effectively cut and seal soft tissue. The flexible nature of the device promises new ways to utilize advanced energy across a wide range of transluminal and other advanced modes of surgical access.

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