The meteoric rise of Motiva implants received a further boost last week when the U.S. Food and Drug Administration (FDA) approved Establishment Labs' application for an investigational device exemption (IDE).
In order to receive this IDE, Establishment Labs had to submit a stack of documents almost three feet high to support their application and to show that their Motiva Implants are of a sufficient standard to be put on sale in the USA. One of the first things that had to be done was for both of Establishment Labs' manufacturing facilities to be approved by the FDA. This was achieved last year and since then, all Motiva Implants for sale worldwide have been manufactured to FDA standards in facilities approved by the US FDA, the Australian TGA, Brazilian ANVISA, European CE authorities and the the regulatory agencies of Japan and Canada.
The IDE approval enables Establishment Labs to move forward with a single arm, multi-centre study investigating female patients receiving primary breast augmentation, primary breast reconstruction, or revision surgery. The results of the study are expected to support a Pre-Market Approval (PMA) submission to the FDA.
“I’m delighted to have the opportunity to participate in a study that has the potential to bring new insights to the breast aesthetic and reconstruction industry. Motiva Implants are innovative and differentiated, and we hope that these innovations will show significantly improved patient outcomes,” said Dr. Caroline Glicksman, a board certified plastic surgeon and Medical Director of the Motiva Implants clinical trial. “Considerable time was taken to create a robust protocol that studies the safety and efficacy of Motiva Implants, and we have worked closely with the FDA to design a state of the art trial. Our investigators include experienced, knowledgeable, and caring surgeons from the United States, Canada, Sweden, and Germany. The safety of our patients remains our primary goal and we look forward to a successful trial that collects valid scientific data and advances the breast aesthetic and reconstruction industry.”
Juan Jose Chacon Quiros, CEO and Founder of Establishment Labs, added, “Patient safety is Establishment Labs’ highest priority. Our implants are engineered with the latest scientific understanding in material sciences and surface technologies, and our advances in biocompatibility have demonstrated a favourable safety profile for patients worldwide. The start of this trial is an important milestone in our global commercialisation strategy, and only adds to our leadership position as the innovator in this industry. Our decision to pursue a trial in the United States with such a rigorous study design reflects the confidence we have in both the superiority of our product and our manufacturing processes. There is a tremendous opportunity to materially improve the safety and satisfaction of patients seeking breast augmentation or reconstruction surgery.”
Motiva Implants are designed with a TrueMonobloc® shell that results in a strong and durable breast implant with exceptional elasticity for ease of insertion through small incisions. The cell-friendly surface technology behind Motiva Implants has demonstrated low complication rates in recent publications. For better aesthetic outcomes, the soft, form-stable gel fillingallows for optimal shape retention, a natural look, and comfortable feel for women. Establishment Labs maintains strict manufacturing practices and adherence to both United States and European standards.
Roberto de Mezerville, Chief Technology Officer of Establishment Labs, commented, “Establishment Labs is committed to bringing enhanced safety and innovative products to the breast aesthetics and reconstruction fields. Motiva Implants® have a strong and rapidly growing following around the world, and the data is suggestive that they represent a meaningful advance to the industry. I have the highest expectations for this trial, and its impact on surgeons and patients alike.”
About the Motiva Implant Trial
The Motiva Implants clinical study is a single arm, multi-centre trial, designed to measure the safety and effectiveness of the Motiva Implants SmoothSilk®/SilkSurface® and Ergonomix® in subjects who are undergoing primary breast augmentation, primary breast reconstruction, or revision surgery. It is scheduled to start in the second quarter of 2018, pending Institutional Review Board approvals at all selected clinical sites. With a population size of approximately 750 patients over 22 years in age and in up to 40 study sites in the United States, Canada, Sweden, and Germany, subjects will be selected per a strict protocol according to FDA regulations.
Patients meeting the inclusion and exclusion criteria may be enrolled in the study. The primary safety endpoint is based on the incidence, severity, method of resolution, and duration for all complications on a “per-implant” and “per-subject” basis. The use of 3D imaging systems, such as Divina®, performed pre-operatively and at 1-10 years visits, will supplement the data and corroborate the manual measurements performed. An MRI sub-study will be done in parallel to determine the percentage of ruptures, with a subset of the treated population selected to obtain MRIs at 1,2,4,6,8 and 10 years.