Ureteral medical device company BrightWater Medical said today it won FDA 510(k) clearance for its ConvertX nephroureteral stent system designed for treating ureteral obstructions.
The ConvertX System is designed as a single device intended to replace a series of devices and procedures used to treat severe obstructions of the ureter. Traditional interventions require an implanted nephrostomy catheter to externally drain urine and a second procedure to implant a nephroureteral stent to circumvent blockage.
Mountain View, Calif.-based BrightWater’s system is designed to be implanted once and convert from a nephroureteral catheter into a nephroureteral stent without requiring sedation or local anesthesia.
“Ureteral blockages due to kidney stones, tumors or scarring from previous surgeries must be treated quickly so urine can be voided. The ConvertX System saves the patient the risk and discomfort of an additional second interventional procedure and may reduce healthcare costs, free up the hospital’s angio suite for other procedures and save the IR procedural time that can be devoted to care of other patients,”BrightWater founds & CEO and ConvertX System developer Dr. Bob Smouse said in a press release.
In addition to the clearance, BrightWater said it recently received a medical device manufacturing license from the California Department of Public Health.
The company also said it plans to submit an application for CE Mark approval in the European Union for the device in the future, and that it is in the process of developing additional ConvertX-based products for other procedures in interventional radiology.
“The ConvertX System is the kind of technology advancement that we require to meet the dual goals of improving patient care and reducing the financial burden to the health care system. Interventional radiology enables patients with severe ureteral blockages to be quickly treated, and technologies like the ConvertX platform provide the IR with simpler, more cost-effective solutions,” Dr. James Benenati of the University of South Florida College of Medicine said in prepared remarks.
In May, BrightWater said it closed a $5.2 million Series A round of financing to support its ConvertX Nephroureteral stent system designed for treating severe ureteral obstructions from development to regulatory filing.
The round was led by OSF HealthCare investment arm OSF Ventures, and joined by angel groups and private investors, the company said.
Funds are slated to be used to cover initial cost for product development, intellectual property and regulatory filings for the ConvertX system.