Sanford radiologist receives 510(k) clearance for catheter
Contact:
Jon Berg
Sanford Health Media Relations
605-366-2432 / Jon.Berg@sanfordhealth.org
SIOUX FALLS, S.D. — A catheter created by Bruce Gardner, M.D. radiologist at Sanford Health in Bismarck and produced by InnoCare Urologics, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its EgressTM Foley catheter under the newly created FDA product classification code recognizing Foley catheters with safety features (SCT). This achievement marks the Company’s first FDA clearance of its platform technology and the first-ever device cleared under this new code.
The EgressTM catheter, patented by Sanford Health, avoids the injuries that occur when traditional indwelling catheters are pulled out while the catheter balloon is still inflated. InnoCare’s proprietary technology enables the EgressTM balloon to automatically deflate before a pull-out occurs, avoiding extensive patient harm. The catheter is readily interchangeable with existing Foley catheters in clinical practice and patient use.
“A pulled-out catheter has typically led to significant bleeding, extended catheterization time, and reparation surgery, requiring diversion of resources and longer hospital stays for an already impacted patient population,” said Dr. Bruce Gardner, radiologist at Sanford Health and inventor of the catheter. “The EgressTM catheter is a safer alternative, particularly among patients in the ICU and those with delirium or dementia who are at the highest risk of pulling out their catheters.”
Foley catheters are one of the most widely used medical devices, with over 30 million prescribed in the U.S. each year. InnoCare will be releasing the catheter to select hospitals and is exploring strategic commercial partnership opportunities in parallel.
“We saw a clear need to innovate a catheter design that has seen minimal advancement since its introduction over 75 years ago,” said Bryan Pinchuk, CEO of InnoCare Urologics. “The creation of this new classification code validates the need to reduce healthcare costs while providing a safer alternative to traditional Foley catheters. We are excited to bring a technology to market for millions of high-risk patients, and this milestone is a critical step in achieving that goal.”
For more information about InnoCare Urologics, visit innocareurologics.com.
About InnoCare Urologics, LLC
InnoCare Urologics, LLC is a privately-held medical device company headquartered in Miami, FL. The Company is developing a suite of proprietary indwelling safety urinary catheters focused on improving patient outcomes and reducing healthcare costs.
About Sanford Health
Sanford Health, the largest rural health system in the United States, is dedicated to transforming the health care experience and providing access to world-class health care in America’s heartland. Headquartered in Sioux Falls, South Dakota, the organization serves 1.4 million patients and nearly 200,000 health plan members across 250,000 square miles. The integrated health system has 45 hospitals, 211 clinic locations, more than 160 Good Samaritan Society senior living centers, 2,900 Sanford physicians and advanced practice providers, 540 active clinical trials, and nine world clinic locations around the globe. Learn more about Sanford Health’s commitment to shaping the future of rural health care across the lifespan at sanfordhealth.org or Sanford Health News.