#SFHS2609466ADecree enrolling the Biodegradable Spacer Balloon by BIOPROTECT
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This law officially includes the Biodegradable Spacer Balloon, known as BALLON BIOPROTECT, manufactured by BIOPROTECT, in the list of reimbursable medical products. The device is intended for use in preventing rectal toxicity in prostate cancer patients undergoing external radiotherapy. It is designed to be implanted in the body for at least 90 days before safely degrading.
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Key Changes
- Inclusion of BALLON BIOPROTECT in the reimbursable medical products list
- Specific indications for use in prostate cancer radiotherapy
- Requirements for medical professionals for implantation
Obligations
What this law requires
Only interventional radiologists, oncologist-radiotherapists, or urologists may perform BALLON BIOPROTECT implantation via transperineal injection
Medical facilities must equip the technical platform with transrectal ultrasound (ETR) equipment with lateral emission capability, providing both sagittal and axial views before performing implantation
Medical facilities must have a stabilizer or 'stepper' device available to secure, support, and manipulate the transrectal imaging probe during BALLON BIOPROTECT implantation
One safety spacer balloon must be used per implantation procedure
BALLON BIOPROTECT implantation is only reimbursable for prevention of rectal toxicity from curative external radiotherapy for prostate cancer in low-risk or intermediate-risk patients