Gallstone complications are a growing crisis. 

1.2M+

procedures performed annually in the U.S.

10 - 20%

of adults affected by gallstones worldwide

10 - 20%

complication rate clearing gallstone obstructions with current methods

  • The biggest risks for gallstone formation are obesity, as well as surgery or medications to enhance weight loss.*

  • Complications from gallstones may include extreme pain, infection and pancreatitis leading to high morbidity and occasional mortality.

  • Surgeons are seeking solutions to deal with the rapidly increasing incidence of disease. Current methods are time consuming, expensive and cumbersome.

  • As GLP-1 use for obesity and diabetes rises, so does gallbladder complication risk. A meta-analysis of 76 RCTs found a 37% higher relative risk of gallbladder complications with GLP-1 use.*

  • An ERCP is done electively within 30 days of stent placement.

*Reference on Resource page

The Care Pathway

In the image to the left, the blue “Freestone” image shows how the process could jump from step 3 to 9. Select any step below for more detail on the current standard of care.

*The sequence of diagnostic steps, ERCP and Surgery, may vary.

  • Gallstone symptoms typically begin as intermittent, cramping pain in the upper right abdomen, often after eating — usually the first sign that prompts a patient to seek care.

  • Persistent or worsening pain brings the patient to the ED, where the workup for a possible gallstone complication begins.

  • Blood work checks liver enzymes, bilirubin, and signs of infection or inflammation; ultrasound is typically the first imaging step to look for gallstones, gallbladder inflammation, or bile duct obstruction.

  • If a complication is confirmed or suspected, the patient is admitted to the hospital for further workup and treatment rather than discharged from the ED.

  • CT imaging may be used for a more detailed look at the biliary system, pancreas, and surrounding anatomy when the diagnosis or extent of complication is still unclear.

  • Gastroenterology evaluates whether an obstructing stone is present in the bile duct and helps plan the next diagnostic or therapeutic step.

  • Magnetic resonance cholangiopancreatography gives a detailed, non-invasive view of the bile and pancreatic ducts to confirm an obstructing stone before committing to an invasive procedure.

  • Endoscopic retrograde cholangiopancreatography is performed to remove the obstructing stone from the bile duct, often involving stent placement.

  • Surgery evaluates the patient for cholecystectomy, the definitive treatment for gallstone disease.

  • The gallbladder is surgically removed to prevent further stone-related complications, typically completing the care pathway.

The FREESTONE Convenience Advantage

FREESTONE solutions are designed to give surgeons the medical device technology needed to relieve an obstruction in a few simple steps.

  • CONVENIENT CARE - Surgeons can treat the condition first by removing the stone or facilitating an elective ERCP.

  • FREESTONE devices are designed to make surgical management of biliary obstructions easier for surgeons to relieve.

  • Patient care is OPTIMIZED, bypassing several time consuming steps.

  • Our methodology enhances PATIENT-CENTERED CARE by providing convenient local care at their chosen hospital instead of costly transfers.

  • Early intervention optimizes the potential for IMPROVED OUTCOMES and fewer complications.

  • Our methodology is easy to LEARN, TRAIN, and IMPLEMENT.

  • The potential for shorter stay and fewer complications result in LOWER COST OF CARE.