List of Salient Characteristics.docx

Description of Requirement:

The George E. Wahlen Salt Lake City Veterans Affairs Health Care System (SLCVAHCS) Radiology/ Oncology Department has a re-occurring annual need for approximately ninety (90) oparticle embolization beads (“PEB”) that will be used in embolization of specific areas of the human vascular system and delivery of chemotherapy treatment, while embolizing the blood vessels within the desired timed stage of the process. Chemotherapeutic agent will be delivered to induce hyper-vascularized tumors and arteriovenous malformation necrosis to help suppress cancer cell activity during the procedure. PEBs must have a controlled embolization system capable of embolizing the blood vessels of a variety of hyper vascularized tumors and arteriovenous malformation, including minimally invasive (non-surgical) malformations (abnormalities), as well as abnormal growths of benign or malignant tissue, which increase in size due to over-development of blood vessels supplying the affected area.

Salient Characteristics: The product must meet, each of the following salient characteristics:

1. Must be a single use, one patient application

2. Must be between 100 to 300 Um, as it will be used in the treatment of liver tumors

3. Must be Non-pyrogenic – to safely prevent activation of inflammatory process, and/or fever

4. Microspheres- must be capable of holding large amounts of water or other substance such a doxorubicin. Must conform to specified size after loading doxorubicin and allow the bead to allude said drug into the anatomical area. This process is performed using sterile water.

5. Must be biocompatible to safely prevent any real or potential harm to human t tissue

6. Must be hydrophilic – to mix well with, dissolve in, or be welted by water

7. Must be non-resorbable- to ensure it safely stays in the location it’s placed in and it’s not absorbed by the organ or the human anatomy treated

8. Must be produced from a material that allows the beads to: a) maintain uniform shape and stability- a critical aspect while delivering said beads through a micro catheter, and b) bind and charge doxorubicin.

9. Must be capable of being used to embolize Hyper Vascular Tumors and Arteriovenous Malformations (AVM) that restrict arterial blood flow to a cancer laden tumor, to prevent it from growing larger. It must have the same effect in AVM

10. Must be capable of having a 2ml bead in non-pyrogenic sterile physiological buffered saline

11. Must be capable of safely tolerating temporary compression of 20% to 30% to facilitate a safe passage through micro catheter

12. Must have the ability to absorb contrast media and doxorubicin to allow easy/safe observation of embolization beads under fluoroscopy and deliver chemo drug to the abnormal tissue, while treating the cancerous/abnormal area

13. Must be capable of binding doxorubicin to the embolization beads, providing a time released treatment of chemotherapy. The beads must occlude the vessel feeding blood to the tumor (post chemotherapy) to minimize, to the highest extent possible, the need for additional treatment to eliminate: a) additional cost, and b) increased patient radiation exposure due to multiple treatments

14. Must be available on demand and delivered to Interventional Radiology within 24 hours of placing an order

15. Must have a 2-years shelf life

16. Must be designed to be safely used to treat the following areas: neurological and peripheral vascular systems, including the neck, spine, liver, genitourinary tract, limbs, lungs, uterus, and gastrointestinal system

17. Must be cleared by FDA for the embolization of hyper vascularized tumors and AVMs. (Please, include any pertinent clearance related information for consideration.)