Silk Voice | Vocal Fold Augmentation Injectable

Silk Science for Advanced Regeneration

Silk Voice is the first & only 510(k) -cleared silk protein injectable for tissue bulking in vocal fold medialization and vocal fold insufficiency

When injected, Silk Voice provides immediate volume augmentation to the vocal fold tissue. The porous particles remain at the site of implantation, providing a scaffold for local tissue infiltration. This cellular infiltrated silk scaffold provides the long term restoration and augmentation. Silk particles, combined with a crosslinked hyaluronic acid carrier, enables initial volume restoration which is replaced with new tissue over time. Shown to provide immediate medialization of the vocal fold and projected to last a minimum of 12 months. A slow absorption profile sets silk apart from other biomaterial such as collagen, elastin, and keratin.

PENTAX Medical America, Inc. 3 Paragon Drive Montvale, NJ 07645 United States

T: +1 201 571 2300 F: +1 201 799 4089 E:

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POROUS SILK PARTICLES

CATHETER INJECTION

TISSUE REGENERATION & COLLAGEN FORMATION

Electron Microscope image of the highly porous micro-architecture of injectable silk particles.

Depiction of catheter injection guided by laryngoscopy.

Histological evaluation of implanted scaffold in canine vocal fold model.

FAQs

Other Injection Methods

Catheter Delivery System

Silk Voice Material

Overview

SILK VOICE MATERIAL

Exposed needle for injection

Needle insertion

Injection of Silk Voice

Wider view of the vocal fold

The proprietary Silk Voice delivery catheter is designed to function with a channeled endoscope for single operator use. The catheter utilizes a custom 23G actuating needle, angled to improve line of sight. The advanced catheter delivery system accommodates low extrusion force and facilitates ease of injection.

Catheter Delivery System

Silk Voice can also be injected via percutaneous injection. When injecting percutaneously, 21G needles are recommended. Silk Voice model SV-1001 includes one 1cc syringe of Silk Voice and two 21G needles for percutaneous injection.

'Regenerated' Silk Protein Solution

Conversion to porus microparticle

Porus Silk Microparticle (350 + 20 micron diameter)

Addition of Cosslined HA Carrier

Silk Voice Injectable Inplant

FDA 510k-cleared Silk + Hyaluronic Acid Designed to provide immediate bulking and longer lasting effect

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If you have any questions or would like to learn more about Silk Voice, please contact us. Our product and service experts are ready to help.

Frequently Asked Questions

How long will the effect of Silk Voice last?

The effect of Silk Voice may be permanent, however the Silk Voice material itself is unlikely to remain in the vocal folds. When treated with Silk Voice, most patients can expect improvement in voice quality or other VFI symptoms for at least 18 months.

Are there any side effects?

It is not uncommon for patients to experience a sore throat, pain in the ear on the side of the injection and bruising or swelling of the neck skin if delivered via percutaneous injection. There are also rare cases of vocal fold swelling in the first week following injection that has led to difficulty breathing.

Who should I inject with Silk Voice? Can I inject in multiple locations and/or re-inject?

Silk Voice has been used in patients with unilateral vocal fold paralysis, unilateral vocal fold atrophy, and bilateral vocal fold atrophy. Re-injection can be performed when needed.

What is the reimbursement code for Silk Voice?

Silk Voice injections have been performed under CPT code 31574.

How can I receive more information or order Silk Voice?

Thank you for your interest in Silk Voice. While the Silk Voice product line is still in Limited Market Release, please enter your information below and your PENTAX Medical representative will get in touch with you.

* October 22, 2020 ** K180631

Catheter Delivery System

Other Injection Methods

United States

EMEA Region

PENTAX Medical Website

Visit Silk Voice Site for Clinicians

PENTAX Medical Website

Visit Silk Voice Site for Clinicians

Visit Silk Voice Site for Patients

Silk protein is a natural, biodegradable material. Regenerated silk protein converted to porous silk microparticles make up Silk Voice’s proprietary formulation with the addition of a crosslinked hyaluronic acid carrier. Silk microparticles have been engineered to match the biomechanics of soft tissues and provide an ideal environment for cellular infiltration, providing a platform for small gauge injectable delivery. Silk Voice is more viscous and cohesive than similar substances, leading to better bulking and less migration within the vocal folds.

The Silk Voice vocal fold injectable and catheter delivery system, manufactured by Sofregen Medical, are currently unavailable. If you have an outstanding order for Silk Voice, models SV-1001, SV-2001, and/or SV-3001, your local sales representative will follow up with you to provide you an estimated delivery date once available. Please fill out the form to be notified when Silk Voice becomes available for purchasing again.

2024 IMPORTANT UPDATE

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PENTAX Medical America, Inc. 3 Paragon Drive Montvale, NJ 07645 United States

T: +1 201 571 2300 F: +1 201 799 4089 E:

PENTAX Medical Website

Cookie Policy

salessupport2@petaxmedical.com

United States

EMEA Region

DEFINA HD Endoscopy

Networking Solutions

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PENTAX Medical Website

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PENTAX Medical America, Inc. 3 Paragon Drive Montvale, NJ 07645 United States

T: +1 201 571 2300 F: +1 201 799 4089 E:

PENTAX Medical Website

Cookie Policy

salessupport2@petaxmedical.com

United States

EMEA Region

DEFINA HD Endoscopy

Networking Solutions

Performance Endoscopy

DEFINA HD Stroboscopy

PENTAX Medical Website