In December 2007, Northern Michigan Regional Hospital began participation in the PROTECT II trial which studies the Impella 2.5 device from Abiomed, Inc. The device is used during high-risk Percutaneous Coronary Intervention (PCI) procedures to support the heart of patients considered too high-risk for routine revascularization, or those with a weak heart.
The Impella 2.5 allows a patient, who otherwise would have to be medically treated, to have a PCI. The device helps the heart to pump and allows the patient's heart to rest.
Dr. Duane Schuil, MD, PhD, and Dr. Louis Cannon, MD, inserted the first device in December 2007, with subsequent cases with Dr. Mark Ginkel, MD. The data and information collected from this study in part supported the submission for FDA approval, making this technology available for use by all physicians in the United States.
The Impella 2.5 subsequently received 510(k) clearance from the FDA, and is now available at the hospital as an FDA approved device.
On Tuesday, April 28, Dr. Harry Colfer, MD, successfully performed the first PCI with the support of the Impella 2.5, post FDA approval.