FDA 510(k) Clearance for Nurse-Designed Rectal Delivery Drug Catheter

Hospi Corporation, a privately-held medical device company focused on nurse-invented products that optimize patient care, has gained FDA 510(k) clearance for its first product, the Macy Catheter™. The Macy Catheter is the only device designed and approved solely for ongoing rectal delivery of medications and liquids.

Background

Invented by a 20-year veteran hospice nurse, the Macy Catheter 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.

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 in the United States 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[1], 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.

Company comments

“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.”

[1] NHPCO Hospice Facts and Figures, 2012 Edition, National Hospice & Palliative Care Organization

Source: Hospi Corporation, PR Newswire

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