Fluoroplastic Partial Prosthesis ( PORP )

Fluoroplastic Partial Prosthesis ( PORP ) Specification

Instruments Type
ENT Surgical Prosthesis

Features
Biocompatible, Lightweight, Radiolucent, High Stability, Non-corrosive, Non-allergenic

Shelf Life
5 Years

Usage Type
Single Use (Disposable)

Measurement Range
Designed for Ossicular Gap, Custom Sizes

Accuracy
Anatomically Precise, Designed for Optimal Sound Transmission

Function
Restores Ossicular Chain Continuity, Improves Hearing

Storage Instructions
Store in Cool, Dry Place; Protect from Direct Sunlight

Equipment Type
Ear Prosthesis / Ossicular Replacement Prosthesis

Material
Fluoroplastic (Polymethylpentene, PMP)

Condition
New

Technology
Molded, Medical Grade Fluoropolymer

Portable
Yes

Wall Mounted
No

Real-Time Operation
Yes

Noise Level
Silent

Operating Type
Manual, Surgical Application

Use
Partial Ossicular Reconstruction (PORP) in Ear Surgery

Power Source
Not Required / Manual Use

Dimension (L*W*H)
Varies with model; typically 2-5mm long

Weight
<1g

Color
White (Opaque)

MRI Compatibility
MRI Safe and Compatible

Shape/Type
Partial Prosthesis (PORP), with Head Plate and Shaft

Flexural Modulus
High (Prevents Deformation)

ISO Certification
ISO 13485 Certified Manufacturing

Packaging Type
Individually Blister Packed

Intended Patient Group
Adults and Children with Middle Ear Ossicular Defects

Sterilization
ETO Sterilized; Sterile Packaging

Compatibility
Suitable for Partial Ossicular Chain Reconstruction

Radiopacity
Radiolucent (X-ray Transparent)

About Fluoroplastic Partial Prosthesis ( PORP )

To compare audiometric results between the standard total ossicular replacement prosthesis (TORP-S) and a new fat interposition total ossicular replacement prosthesis (TORP-F) in pediatric and adult patients and to assess the complication and the undesirable outcome.

Study design:

This is a retrospective study.

Methods:

This study included 104 patients who had undergone titanium implants with TORP-F and 54 patients who had undergone the procedure with TORP-S between 2008 and 2013 in our tertiary care centers. The new technique consists of interposing a fat graft between the 4 legs of the universal titanium prosthesis (Medtronic Xomed Inc, Jacksonville, FL, USA) to provide a more stable TORP in the ovale window niche. Normally, this prosthesis is designed to fit on the stapes head as a partial ossicular replacement prosthesis.

Results:

The postoperative air-bone gap less than 25dB for the combined cohort was 69.2% and 41.7% for the TORP-F and the TORP-S groups, respectively. The mean follow-up was 17months postoperatively. By stratifying data, the pediatric cohort shows 56.5% in the TORP-F group (n=52) compared with 40% in the TORP-S group (n=29). However, the adult cohort shows 79.3% in the TORP-F group (n=52) compared with 43.75% in the TORP-S group (n=25). These improvements in hearing were statistically significant. There were no statistically significant differences in the speech discrimination scores. The only undesirable outcome that was statistically different between the 2 groups was the prosthesis displacement: 7% in the TORP-F group compared with 19% in the TORP-S group (P=.03).

Conclusions:

The interposition of a fat graft between the legs of the titanium implants (TORP-F) provides superior hearing results compared with a standard procedure (TORP-S) in pediatric and adult populations because of its better stability in the oval window niche.

Keywords: TORP, PORP, ossicular chain, ossicular replacement, hearing loss, conductive, total, partial

Precision Engineering for Hearing Restoration

Our PORP is molded from high-flexural modulus fluoroplastic, ensuring superior durability and resistance to deformation during surgical procedures. With anatomically precise shaping, it helps restore the continuity of the ossicular chain, ultimately improving hearing function for adults and children with partial middle ear defects.

Biocompatibility and Patient Safety

Manufactured using medical-grade PMP and meeting ISO 13485 standards, this prosthesis is both non-allergenic and non-corrosive. Its biocompatibility minimizes the risk of adverse reactions, while radiolucency allows for accurate post-operative X-rays without prosthesis interference.

Sterility and Ease of Use in ENT Surgery

Each PORP comes ETO sterilized and individually blister-packed to ensure absolute sterility for every patient. Designed for single use and easy, manual placement, the prosthesis streamlines the ossicular reconstruction process and supports optimal patient outcomes.

FAQ's of Fluoroplastic Partial Prosthesis ( PORP ):

Q: How is the Fluoroplastic PORP used during ear surgery?

A: The Fluoroplastic PORP is manually placed by an ENT surgeon to bridge the gap in the ossicular chain, restoring sound conduction. Its head plate and shaft design fit precisely in the middle ear, ensuring stability and optimal sound transmission without requiring any power source.

Q: What benefits does a fluoroplastic prosthesis offer over other materials?

A: Fluoroplastic (PMP) is non-corrosive, lightweight, and biocompatible, reducing risks of allergic reaction or tissue irritation. Its high flexural modulus prevents deformation, while radiolucency allows clear imaging without artifact on X-rays and MRI scans.

Q: When should a PORP be considered for a patient?

A: A PORP is recommended for adults and children with partial defects of the middle ear ossicular chain, where anatomical continuity needs to be restored to improve hearing following trauma, infection, or congenital malformation.

Q: Where is this prosthesis manufactured and does it meet international safety standards?

A: The prosthesis is supplied and distributed in India and is manufactured following ISO 13485 certified processes, ensuring it meets international medical safety and quality benchmarks.

Q: What is the process for sterilizing and packaging this PORP?

A: Each PORP undergoes ethylene oxide (ETO) sterilization, then is sealed in an individual blister pack. This guarantees sterility until the packaging is opened for the surgical procedure.

Q: Is the device MRI-compatible and can it be detected on X-ray?

A: Yes, the prosthesis is MRI-safe and compatible. It is radiolucent, meaning it does not appear on X-ray images, thus avoiding interference with post-operative diagnostic imaging.

Q: What storage conditions are required for the PORP before surgical use?

A: Store the PORP in a cool, dry place and protect it from direct sunlight to maintain its sterility and shelf life, which is up to 5 years as per manufacturer's guidelines.