FDA OKs urinary prosthesis, lymphatic mapping agent

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In separate actions, the FDA allowed the marketing of a urinary prosthesis for women and approved a supplemental new drug application for a lymphatic mapping agent.

In separate actions, the FDA allowed the marketing of a urinary prosthesis for women and approved a supplemental new drug application (sNDA) for a lymphatic mapping agent.

The FDA has allowed marketing of the inFlow Intraurethral Valve-Pump, a replaceable urinary prosthesis for use in female adults with impaired detrusor contractility (IDC).

‘The inFlow is intended to address catheter-related problems and, as a prosthetic device, to compensate for a specific anatomic deficiency,” manufacturer Vesiflo, Inc. said in a press release.

The device consists of four components: a sterilized, single-use urethral insert component with silicone shaft, fins, and flange; an introducer; an activator; and a sizing component. The device draws urine out to empty the bladder and blocks urine flow when continence is desired. A physician sizes the patient for an inFlow device and performs the initial insertion. After training, device insertion and removal can be performed by the patient or a caregiver.

In a press release, the FDA said it reviewed data for inFlow through the de novo classification process, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to a legally marketed device. The de novo request was granted based on non-clinical testing and a clinical trial that enrolled 273 women with IDC using clean intermittent catheterization (CIC). Over half of the women stopped using the device as a result of discomfort and urine leakage. The trial showed that 98% of the 115 women who continued to use the inFlow device had comparable post-void residual urine volume with those who used the CIC.

“The inFlow device allows women with IDC to urinate, without the need to catheterize daily or be attached to a urine drainage bag. This may allow for increased mobility and the ability to be more self-sufficient,” said William Maisel, MD, MPH, of the FDA’s Center for Devices and Radiological Health.

In Vesiflo’s press release, CEO Kevin M. Connolly said the device “allows almost normal use of a toilet.”

“[inFlow] eliminates the need to catheterize multiple times daily, eliminates tubes and drainage bags, and restores personal dignity to a population in acute need,” Connolly said.

The FDA noted that the most significant of the adverse events associated with the inFlow-urinary tract infection-appears to occur at a lower rate with the inFlow device than with CIC. Among patients treated with the inFlow device, “UTIs were stable and easily managed with antibiotics,” the FDA release said.

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Separately, the FDA approved an sNDA for the expanded use of technetium Tc 99m tilmanocept (Lymphoseek) injection for lymphatic mapping in solid tumors. The agent is now indicated for lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors (including prostate tumors) for which this procedure is a component of intraoperative management.

The FDA also allowed expanded utilization of technetium with or without lymphoscintigraphy to enable preoperative imaging and mapping of lymph nodes to facilitate node localization during surgical procedures, according to a press release from Navidea Biopharmaceuticals.

“Lymphoseek is now the only agent approved by the FDA for lymphatic mapping across solid tumors when used as a component of surgical management. This significantly expands the potential market for Lymphoseek and materially enhances the company’s ability to promote the use of Lymphoseek in solid tumor cancers where assessment of lymphatic involvement is critical to properly staging the disease, especially colorectal, gynecological, lung, and prostate cancers,” said Michael Goldberg, MD, of Navidea Biopharmaceuticals.

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