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FDA Updates

Placental Allografts for Diabetic Foot Ulcers

Epix is a top-notch allograft system used to treat diabetic foot ulcers and developed by MiMedx, a Georgia-based company. This particular type of graft is synthesized from donated human placental tissue. After acquiring the donor’s consent, the obtained tissue is processed through a complex cleaning and dehydration process for a posterior long life-shelf storage at room temperature. (1)

Diabetic foot ulcers are a frequent cause of hospitalizations for complicated infections in Diabetic patients. There is little to non-consensus for an effective treatment option, and therefore a failed prevention of complication-related hospitalizations. Epix allograft works as a semipermeable membrane that functions as a protective layer that supports and facilitates the wound’s healing process by stimulating the granulation process, thus improving the healing of acute and chronic wounds. (1)

Epix is a top-notch allograft system used to treat diabetic foot ulcers and developed by MiMedx, a Georgia-based company. This particular type of graft is synthesized from donated human placental tissue. After acquiring the donor’s consent, the obtained tissue is processed through a complex cleaning and dehydration process for a posterior long life-shelf storage at room temperature. (1)

Diabetic foot ulcers are a frequent cause of hospitalizations for complicated infections in Diabetic patients. There is little to non-consensus for an effective treatment option, and therefore a failed prevention of complication-related hospitalizations. Epix allograft works as a semipermeable membrane that functions as a protective layer that supports and facilitates the wound’s healing process by stimulating the granulation process, thus improving the healing of acute and chronic wounds. (1)

The Epix comprises a dehydrated human amnion-chorion membrane and is first obtained from consenting donors after an elective C-section. After preserving the tissue’s extracellular membrane and adding regulatory proteins, it undergoes a process called Purion®, eliminating all blood-related contaminants. And it is later sterilized. The resulting product is an easy and safe storage, durable potent graft. Epix is readily available in several presentations like a sheet, mesh, or any other configuration. (1)

Wireless Smart Catheter for Bladder Control

The IntelliFlow bladder management system is an intelligent transurethral catheter developed by UroDev. This product consists of a wireless internal catheter control with an extracorporeal magnetic remote. Its primary purpose is to avoid repetitive, uncomfortable, intermittent bladder catheterization in patients with urinary retention.

 

Patients with chronic urinary retention empty their bladders around five to seven times a day with intermittent catheterization, resulting in the use of more than 200 single-use disposable catheters in a week. This constant procedure increases these patients’ risk of urinary infections and hospitalizations due to subsequent complications. (2)

IntelliFlow is an innovative approach to the chronic intermittent catheterization situation. By implanting a noninvasive, semi-permanent catheter that contains a magnetic valve and a urine pump, the user can wirelessly release the valve and activate the pump. Therefore, letting the urine flow, thus emptying the bladder. IntelliFlow can reside within the urinary apparatus for approximately one week.

The catheter’s longer life improves the patient’s quality of life by decreasing the endless need for daily replacements and their risk of chronic urinary infections. Furthermore, it can be easily inserted or removed by the user or clinician, eliminating the need for extracorporeal urine-collecting bags. (2)

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