a spokesperson for its manufacturer, Medtronic, confirmed.
In a June 22 email, company representative Oded Cojocaru stated that the decision followed “several months of ongoing challenges with reliable supply of critical components to our SmartPill motility testing system.”
The SmartPill motility testing system’s maturity “means we cannot source an alternative supplier for the specialized components required to manufacture the SmartPill capsules and recorders. As a result, we have made the difficult decision to discontinue global sales,” Mr. Cojocaru said.
Customers have been notified and all sales of the device will be discontinued across all clinical applications when available inventory is exhausted, which is expected to occur in September. Medtronic has no plans to develop an alternative to the device.
Massachusetts General Hospital
Dr. Braden Kuo
Braden Kuo, MD, of Massachusetts General Hospital, Boston, a motility specialist who took part in the SmartPill’s development and testing at various stages, said that Medtronic’s decision to discontinue the device was already known among his GI colleagues, and was the subject of concern as there is no analogous Food and Drug Administration–approved device on the market.
While the device’s clinical adoption “is not extremely widespread,” Dr. Kuo said, thousands of SmartPills are still used in GI clinics every year, and insurance tends to cover their use, especially in major metropolitan areas.
Originally developed by the SmartPill Corporation of Buffalo, N.Y., the device was first cleared by the FDA in 2006 for the evaluation of colonic transit time in patients with chronic constipation and suspected gastroparesis. Six years later that company was sold to Given Imaging, an Israeli firm making ingestible capsule endoscopy devices with cameras. In 2015, Given Imaging was purchased by Medtronic.
The SmartPill is ingested under clinical supervision, after which a patient can return home and allow the capsule to pass naturally through the body over a period of days. It is used in tandem with proprietary monitoring hardware, software, and a special food product. Known limitations of the device include that it can be difficult for some patients to swallow, and that it can get stuck in the lower digestive tract. Its use is contraindicated in patients with dysphagia, stricture, or bowel obstruction.
“Many motility doctors and some general GI docs find this test helpful,” said Dr. Kuo, who formerly served as a scientific adviser to SmartPill and later ran trials of the technology for Medtronic. It is useful as an alternative to costlier scintigraphy, he said, or to follow up after a negative endoscopy result.
The SmartPill has also been fruitful for GI research, Dr. Kuo added, because the capsule is easy to administer, compared with nonambulatory ways of studying motility, which limited enrollment. “Now we can do studies with several hundred people, because this is much more easily tolerated, and we’ve made a lot of interesting insights about GI physiology and pathophysiology as a result of this technology.”
During its 17 years on the market, Dr. Kuo said, the SmartPill has helped galvanize interest in other capsule applications, including for drug delivery, imaging and sampling.
Dr. Jack Semler
Dr. Jack Semler
Jack Semler, PhD, the former chief technology officer of SmartPill and who alongside Dr. Kuo has coauthored some 40 papers on the SmartPill, said he, too, lamented the decision by Medtronic. “The company has only so many resources to devote to upgrading technology and those resources just aren’t available for this particular product,” he speculated. Nonetheless, Dr. Semler said, “I still feel there is a real untapped potential.”
Dr. Kuo and Dr. Semler both disclosed previous paid work for SmartPill and Medtronic. Both are currently consulting for Atmo Biosciences, a company that is developing a different motility capsule technology.
