San Francisco, CA (UroToday.com) -- Lazarus 3D received its first 510(k) clearance from the Food and Drug Administration (FDA) for its patented PRE-SURE® technology. Lazarus 3D's PRE-SURE® models are created in synthetic, soft-tissue materials that can be cut, sutured, and can even bleed. These hyper-realistic models are 3D printed directly from patient MRI/CT data to allow doctors to perform surgical rehearsals before operating on the actual patient. This clearance covers all genitourinary conditions, including conditions of the kidneys, prostate, bladder, and genitalia.
“Traditionally, surgeons utilize 2D imaging studies and occasionally 3D imaging reconstructions to understand a patient’s particular anatomy and tumor configuration. This has obvious limitations and prevents surgical rehearsal. Physical 3D models have been limited in availability, and their hard plastic design limits their usefulness. PRE-SURE® is a unique technology that provides physical patient- specific 3D organ replicas that aid in surgical planning and allow for surgical rehearsal. These models are also extremely useful for both patient and trainee education,” said Dr. Wesley A. Mayer, MD, Vice Chair of Education and Associate Professor of Urology at Baylor College of Medicine."We build our models to imitate the patients’ organs so that surgeons can practice their upcoming procedures before the patient enters the hospital. This can reduce risk to patients and help surgeons achieve surgical perfection,” said Dr. Jacques Zaneveld, Founder and CEO of Lazarus 3D.
The American Medical Association (AMA) has issued medical billing codes covering Lazarus 3D’s technology. Lazarus 3D PRE-SURE® models will be covered by major health insurance plans facilitating rapid adoption across the United States. PRE- SURE® models are designed, produced, and directly delivered to the surgeon, providing a turn-key solution that can help improve surgical outcomes for over 32,000 kidney cancer patients in the US annually.
“Just like practice leads to perfection for an orchestra, surgical rehearsals on PRE- SURE® models inspire confidence in surgeons and patients. These models may lead to markedly improved patient outcomes and become a new standard of care for a wide range of complex procedures,” said Dr. Smriti Zaneveld, Founder and President of Lazarus 3D. “This technology has the potential to significantly reduce the US healthcare burden resulting from surgical complications.”
Lazarus 3D, headquartered in Albany, Oregon, was founded in 2016 to develop innovative solutions that help doctors operate with confidence. Lazarus 3D's patented PRE-operative SUrgical REhearsal (PRE-SURE®) technology allows physicians, for the first time, to rehearse on realistic copies of patients’ organs before operating on the patient. These unique life-like models are 3D printed directly from patient's MRI/CT data and are FDA cleared for pre-operative surgical rehearsals for all genitourinary conditions, including conditions of the kidneys, prostate, bladder, and genitalia. Lazarus 3D’s mission is to enable surgical perfection by bringing PRE-SURE® technology to every patient and every surgeon.
Source: 3D, Lazarus. 2021. "Lazarus 3D Announces First FDA Clearance For Preoperative Surgical Rehearsal (PRE-SURE®) Technology". Prnewswire.Com.