FDA grants clearance to soft-tissue 3D printing technology for GU conditions

The FDA has granted 510(k) clearance to Lazarus 3D for its PRE-SURE 3d printing technology for use across all genitourinary (GU) conditions.¹

The technology produces synthetic, soft-tissue models with a lifelike quality—including bleeding—that allows clinicians to map out and simulate surgeries in preparation for operating on their actual patients. The PRE-SURE system creates the realistic models directly from patient MRI/CT data. Urology areas covered for this FDA clearance include conditions of the prostate, bladder, kidneys, and genitalia.

The FDA’s 510(k) clearance designation allows a company to market a medical device in the United States if the company can prove to the regulatory authorities that its device is “substantially equivalent” to a device that is already legally marketed in the country.²

Wesley A. Mayer, MD

“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,” Wesley A. Mayer, MD, vice chair of Education and associate professor of Urology at Baylor College of Medicine, stated in a press release.

"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,” Jacques Zaneveld, PhD, founder and CEO of Lazarus 3D, stated in the release.

According to the company , medical billing codes have been issued by the American Medical Association to reimburse for PRE-SURE.

“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,” Smriti Zaneveld, PhD, founder and president of Lazarus 3D, stated in the release. “This technology has the potential to significantly reduce the US healthcare burden resulting from surgical complications.”

References

1. Lazarus 3D Announces First FDA Clearance for PREoperative SUrgical REhearsal (PRE-SURE®) Technology. Published online August 25, 2021. Accessed August 27, 2021. https://prn.to/3znDkPT.

2. 510(k) Clearances. US Food and Drug Administration. Accessed August 27, 2021. https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances