U.S. FDA Grants 510(k) Clearance To Innovative Device For Easy Medication Administration When Patients Are Unable To Swallow
Macy Catheter(TM) is the Only Device Approved in the U.S. Solely for Ongoing Rectal Delivery of Medications and Liquids
NEWARK, Calif., Feb. 13, 2014 /PRNewswire/ — Hospi Corporation, a privately-held medical device company focused on nurse invented products that optimize patient care, today announced receipt of 510(k) clearance from the U.S. Food and Drug Administration for its first product, the Macy Catheter(TM). The Macy Catheter is the only device designed and approved solely for ongoing rectal delivery of medications and liquids.
Invented by a 20-year veteran hospice nurse, the device offers clinicians and caregivers an easy, discreet and comfortable alternative to rectal administration of medication. The Macy Catheter is particularly useful for patients with serious or terminal illness who often lose the ability to swallow.
“Rectal administration is a fast, safe and highly effective route of delivery for many medications, especially those used for management of symptoms at the end of life; however, it is often under-utilized in hospice due to the discomfort and embarrassment associated with suppository administration,” said Brad Macy, RN, BSN, CHPN, co-founder of Hospi, inventor of the Macy Catheter, and recipient of 2013′s National Hospice and Palliative Care Nurse of the Year Award. “Speed of symptom control is important when a person may only have a few hours or days to live, and medications administered rectally in suspension or solution form are generally absorbed more quickly than suppositories. The Macy Catheter transforms rectal delivery of medication by providing a comfortable and discreet way to administer ongoing medications and liquids without repeated invasion of privacy and suppository administration.”
He added, “The Macy Catheter is also easy for clinicians and caregivers to use in the home environment, where it can provide peace of mind to those caring for a loved one who may be struggling with pain and other distressing symptoms at end-of-life. By allowing them to be easily cared for at home, patients can avoid spending their last days at the hospital. Home is where most patients prefer to be.”
Hospi believes the Macy Catheter can enhance hospice and palliative care by decreasing suffering due to pain and other symptoms near the end of life, and by allowing patients to remain in the home setting during their last days.
The Macy Catheter will be sold by Hospi Corporation and available via prescription as a single use, disposable device starting in Spring 2014. Once placed by a clinician, it rests on a patient’s leg or abdomen where it is easily accessible for repeat administration of liquids and medications. The Macy Catheter is constructed of Silicone. It is protected by two issued U.S. patents and has several patents pending.
Although initially the Macy Catheter may be used primarily to manage symptoms for approximately 1.65 million patients in hospice each year, Hospi sees broad applicability for the device whenever a patient has a compromised oral route, such as due to severe nausea and vomiting. Additional market segments where the Macy Catheter may be relevant include palliative care, home health, skilled nursing, and acute care.
About Hospi Corporation
Hospi Corporation is a privately-held medical device company that improves quality of life by innovating practical, high-impact medical devices that enhance patient comfort and wellbeing, ease caregiver burden, and reduce cost. The company’s patient-centric focus, which is informed by a nursing perspective, guided the development of its first product, the Macy Catheter(TM). Hospi Corporation has received Small Business Innovation Research (SBIR) grants from the National Science Foundation and National Institutes of Health to support development of its nurse-invented products. For more information, visit www.hospicorp.com.
 NHPCO Hospice Facts and Figures, 2012 Edition, National Hospice & Palliative Care Organization
SOURCE Hospi Corporation