|Macy Catheter--Courtesy of Hospi|
Hospi announced CE mark approval for its flagship Macy Catheter, the only device on the market that's designed specifically for rectal delivery of fluids and medications.
It consists of a dual-port, dual-lumen ballooned tube that is inserted in the rectum. A retention balloon is inflated via the balloon inflation port to hold the device in place. The Macy Catheter is placed similarly to a standard Foley catheter, but in the rectum rather than the bladder.
Product inventor and hospice nurse Brad Macy was inspired to develop the device after he delivered liquefied medication into a patient's rectum using a urinary catheter.
The Macy Catheter last year earned a 510(k) clearance from the FDA. "While we focus our direct commercial efforts in the United States, we look forward to working with distribution partners in Europe and other markets where the CE mark is required," said Hospi CEO Igal Ladabaum in a statement.
The company also announced that it received ISO 13485 Certification, meaning its quality management system is on par with the global standard.
In addition to expansion into Europe, Hospi is seeking to expand use of the Macy Catheter outside of hospice care settings. Last year the National Science Foundation awarded a $700,000 research grant to the company to study expanded use of the only FDA-cleared device for rectal delivery of medications. The early results look promising.
A paper in the American Journal of Emergency Medicine described three instances of successful use of the drug delivery device in emergency settings at the Advocate Christ Medical Center in Oak Lawn, IL, near Chicago.
Caregivers wrote in the paper that the device is quick and easy to use, and avoids complications like repeated attempts at vascular access. Using the rectal delivery route, the liquefied or crushed medications (including aspirin, oral acetaminophen and methimazole) were found to take effect in as little as one minute or less.
The paper concludes that "a novel rectal administration device appears to offer an appealing alternative route to medication and fluid administration for a variety of indications in acute and critical care settings."
- read the release