A new type of device system being developed by Myka Labs as a potential treatment for a common and highly debilitating condition experienced by nearly every patient with Crohn’s disease was recognized today by the FDA-sponsored Pediatric Device Consortium for its potential to be particularly impactful in the pediatric Crohn’s patient population.
The new type of device, currently in late-stage preclinical studies, pioneers intraluminal compression as a new mechanism of action for treating strictures in the small bowel.
The cycles of inflammation experienced by many Crohn’s patients often result, over time, in scarring within the bowel wall. In bowel segments with pronounced scarring, wall thickening and associated shrinkage of the lumen tends to occur. These segments where the passageway within the bowel has become markedly narrowed are known as strictures.
The extensive fibrosis (scarring) seen in many Crohn’s strictures makes them difficult to treat using even the most advanced medicines. Many patients with strictures undergo surgery to have the segment with the stricture removed.
Experience repairing esophageal atresia using technology originating in the world-renowned UCSF Surgical Innovations Initiative and recently transitioning into the clinical validation stage under the auspices of Myka Labs led UCSF pediatric and fetal surgeon Dr. Mike Harrison to hypothesize that intraluminal compression–squeezing down on a strictured segment along its length from within the lumen, using flange- or disk-like device components positioned on either end–could durably resolve fibrotic stricture through targeted ischemic necrosis with accompanying engineered peripheral healing.
With advanced intraluminal compression device system designs under development by Myka Labs, longitudinal compression therapy can potentially be used to treat Crohn’s small bowel strictures with procedures that are performed entirely endoscopically, preserving bowel length and sparing patients from surgeries involving incisions in the abdominal wall.
The intraluminal compression approach is expected to ultimately be used to treat strictures throughout the hollow viscous. The use of intraluminal compression therapy was noted by the Pediatric Device Consortium as being particularly important for pediatric Crohn’s, given the lifelong nature of Crohn’s disease.