PENTAX Medical Silk Voice™ Patient Site

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

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

silkvoice@pentaxmedical.com

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These are all typically minor and resolve within a few days. You may also experience an increase in secretions coughed up from the lungs due to the benefit and return of a more effective cough. There is expected mild swelling of the injected vocal fold and surrounding tissue (hence the hoarseness in voice that improves over the first 2 to 3 weeks). There are also rare cases of breathing difficulty due to vocal fold swelling in the first week following the injection that would require urgent treatment. Talk with your doctor to review expectations and possible side effects or complications.

After the procedure it is not uncommon to experience a sore throat, have pain in your ear on the side of the injection, and bruising or swelling of the neck skin if the injection route was through the skin.

Are there any side effects?

A more effective cough is typically present right away in the case of vocal fold paralysis. Your voice will also return immediately but then change over the first 2 to 3 weeks, often hoarse at first then improving. Most patients report mild discomfort during and after their procedure. Your doctor may prescribe a period of vocal rest after the procedure and will also likely schedule a follow-up visit. It will be important to follow up on your progress at periodic intervals. In some cases your doctor may recommend a second injection.

Clinical experience has shown immediate improvement in VFI symptoms during the procedure.

What can I expect after the procedure?

It can also be performed in the operating room under general anesthesia or sedation, depending on your comfort and your physician’s preference. The clinical settings in which you will be injected can also depend on your underlying anatomy (shape and build of your nose, throat, and neck) and medical history. For an office-based injection of Silk Voice, you will be seated in a standard examination chair and your nasal passages will be decongested and numbed to allow a camera called a flexible laryngoscope to pass through your nose more comfortably.

Your doctor will then view your vocal folds and provide more topical numbing medicine to your vocal folds. Silk Voice will then be delivered through the laryngoscope using a catheter delivery device (a small tube that goes through the scope itself). The route of office-based injection you will be offered will depend on your physician’s preference, the equipment available to them and your anatomy.

Silk Voice injection is a 15 to 20 minute procedure that is typically performed in your doctor’s outpatient clinic.

What can I expect during the vocal fold procedure?

Silk Voice can help restore your ability to phonate (speak), without surgery. Voice issues can often occur because of improper vocal fold closure leading to VFI. In addition to hoarseness, VFI is often accompanied by vocal strain, effort, and fatigue. This is usually due to decreased or absent movement of one vocal fold or due to the loss of tissue volume due to normal aging (atrophy).

Vocal fold injections to add volume or “bulk” vocal folds are a common procedure performed by Ear, Nose and Throat Physicians and are commonly performed under local anesthesia in the outpatient clinic setting. Silk Voice is designed to add volume to one or both vocal cords, enabling them to close properly (see diagram). Proper closure allows the vocal cords to vibrate properly and then produce sound or generate a stronger cough to clear the lungs and throat.

Your doctor may recommend Silk Voice if you are suffering from symptoms of vocal fold paralysis or if your vocal cords are not closing properly when you speak.

Why is my doctor recommending treatment with Silk Voice?

When treated with Silk Voice, most patients can expect improvement in voice quality or other VFI symptoms for at least 18 months. Your doctor may recommend repeating the Silk Voice treatment or another treatment to extend the results, if needed, over time.

The effect of Silk Voice may be permanent, however the Silk Voice material itself is unlikely to remain in your vocal fold long term.

How long will the effect of Silk Voice last?

VFI occurs when air leaks inappropriately from the vocal folds (vocal cords) during talking and can lead to symptoms of voice change, difficulty swallowing and a weak and ineffective cough. Silk Voice is a gel-like material that is injected into the muscle of the vocal folds to immediately add volume and help restore the ability of the vocal folds to touch and work more normally. Your doctor can inject Silk Voice™ during a 15 to 20 minute, minimally invasive procedure. Over time, your body will begin to replace the silk material with newly deposited tissue which may provide a long-lasting result.

Silk Voice is a novel, FDA cleared material that your doctor may recommend if you suffer from voice change due to vocal fold insufficiency (VFI).

What is Silk Voice?

Frequently Asked Questions

Symptoms can include but are not limited to: • Hoarse voice • Weak voice • Difficulty breathing when speaking • Difficulty swallowing

Our voices are an important part of how we interact with the world.

What are the symptoms for a vocal fold disorder?

The treatment will depend on your diagnosis and the severity of the condition. There are several options available.

• Surgery to improve vocal fold motion. • Treatment with Silk Voice (no surgery required). • Vocal therapy with a Speech Language Pathologist. • Vocal rest. Please speak to your doctor about what option is right for you.

What are my treatment options?

These symptoms do not always require treatment, but if you experience symptoms for over two weeks or symptoms get worse, it may be time to see a doctor. Your doctor will review your medical history and conduct a full examination of your vocal folds. The doctor will pass a camera called an endoscope through your nose so they can view your vocal folds in action. The endoscope will allow them to diagnose and determine treatment options.

When should I seek treatment?

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When one or both vocal folds cannot close properly, a gap is created between the folds so that air can escape, and vibrations do not occur. This condition is known as vocal fold insufficiency. Most patients with this condition complain of voice hoarseness, difficulty swallowing or weak or breathy sounding voice. These symptoms can range from mild to severe. There are many causes for vocal fold insufficiency. Typical causes include overuse of the voice, injury, vocal cord paralysis, tumor, or neurological disorders.

We speak to communicate and convey our emotions. However, sometimes issues can occur that impact our ability to speak, which can be quite frustrating. Often, these issues are caused by problems in the vocal folds.

The vocal folds (or vocal cords) are two bands of smooth muscle located in the larynx (or voice box). When your voice is healthy, your vocal folds open and close causing a vibration that creates the sound of your voice.

INTENDED USE & INDICATIONS Silk Voice is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Silk Voice injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication. CONTRAINDICATIONS • Patients with the presence of foreign bodies, acute inflammation, active • infection, inadequately controlled malignancy, or rapidly advancing disease • that involve the laryngopharynx or upper respiratory tract. • Patients with bilateral laryngeal paralysis or a non-moving vocal fold that • has a chance to recover purposeful motion. WARNINGS • Use of Silk Voice during pregnancy has not been established. • Airway obstruction following vocal fold injection may occur immediately • or at any time up to seven (7) days following injection.

Additional Information

There are also rare cases of breathing difficulty due to vocal fold swelling in the first week following the injection that would require urgent treatment. Talk with your doctor to review expectations and possible side effects or complications.

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Who makes Silk Voice? Silk Voice is produced by Sofregen Medical and is distributed by PENTAX Medical. About Sofregen Medical: Sofregen Medical is a pioneer in soft tissue engineering with an advanced platform based on silk protein, also known as fibroin, which has been shown to have unique properties for tissue support and regeneration. About Pentax Medical: PENTAX Medical is a division of Hoya Group. Its mission is to improve the standard of patient care and enhance patients’ and providers’ experience by providing the best endoscopic products and services with a focus on Quality, Clinically Relevant Innovation, and Simplicity. Through leading edge R&D and manufacturing, PENTAX Medical provides endoscopy solutions to the global medical community. Headquartered in Japan, PENTAX Medical has a worldwide focus and presence, with R&D, regional sales, service, and in-country facilities around the globe. PENTAX Medical employees represent the diverse countries where we do business, allowing us to provide innovative solutions tailored to meet local needs.

If you have any additional questions, please speak to your doctor.

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• Surgery to improve vocal fold motion. • Treatment with Silk Voice™ • (no surgery required). • Vocal therapy with a Speech • Language Pathologist. • Vocal rest.

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

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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:

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