Dr. Andrew Wolfe first Plastic Surgeon to enroll a patient in nation-wide Motiva Implants® IDE Clinical Trial.
GOLDEN, Colo., July 30, 2018
GOLDEN, Colo., July 30, 2018 /PRNewswire-PRWeb/ -- Andrew J. Wolfe, M.D. is the first Plastic Surgeon to enroll a patient in the investigational device exemption (IDE) clinical trial of Establishment Labs' Motiva Implants®. Since enrolling the first study patient in the first week of April, he has enrolled 13 more and has completed breast augmentation surgery on 12 patients using the Motiva Implants®.
Motiva Implants® are currently sold in over 60 countries worldwide but have not yet been approved by FDA. The purpose of this clinical trial is to collect scientific evidence of the safety and effectiveness of Motiva Implants®.
There are only 35-40 study sites in the U.S., Canada, Sweden, Germany and the UK, and Dr. Wolfe is excited to be a part of this elite group of Plastic Surgeons. "This is a great opportunity to dialogue with colleagues across the country who are true leaders and innovators in the industry," he says. Dr. Wolfe goes on to say, "I am slow to adopt a new device or technique in my practice until I have done my due diligence with researching it."
Dr. Wolfe is currently enrolling patients for this clinical trial. Participants must be female patients over 22 years of age who are undergoing primary breast augmentation, primary breast reconstruction, or revision surgery. To be eligible, participants must be willing to attend follow-up visits for 10 years and undergo magnetic resonance imaging (MRI), if needed.
About Andrew Wolfe, M.D.
Dr. Wolfe is a Board Certified Plastic Surgeon and owner at The Center for Cosmetic Surgery (https://www.thecenterforcosmeticsurgery.net/) in Golden, Colorado. He has been in private practice since 2001 and has performed hundreds of breast augmentation procedures. He is known for giving his patients beautiful, natural-looking results.
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