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July 10, 2019

Keystone Heart to Distribute Vasorum's Celt ACD Vascular Closure Device

July 11, 2019—Keystone Heart Ltd. announced that it has entered into a distribution agreement with Ireland-based Vasorum Ltd. for sales and marketing of Vasorum's Celt ACD arterial puncture closure device, which is used after percutaneous catheter-based vascular procedures. Under the agreement, Keystone Heart would begin selling the Celt ACD in the United States and European markets effective July 1, 2019.

According to Keystone Heart, the Celt ACD device achieves closure by applying Vasorum's biocompatible implant to both the inside and the outside of the puncture site in the femoral artery at the level of the arterial wall. The Celt ACD is available in three sizes to fit 5-, 6-, and 7-F sheaths. It is does not require exchange of the existing procedural sheath before deployment.

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July 11, 2019

CDRH Issues Guidance for Live Case Presentations During IDE Clinical Trials

July 11, 2019

CDRH Issues Guidance for Live Case Presentations During IDE Clinical Trials