Be You Again
Spiration Valve System

"[This procedure] is marvelous. It changes your life...it is a second chance at life."

Lucie, SVS Recipient
A few days afterwards, I started feeling normal again, like a mother, a grandmother, and just getting back to doing things that I love to do.
– Marion, SVS Recipient
Marion, SVS Recipient
Ronny, SVS Recipient
I can walk up the stairs, and I'm not out of breath so frequently. I had a major improvement on my life.
– Ronny, SVS Recipient

ENDOBRONCHIAL VALVE TREATMENT

FOR SEVERE EMPHYSEMA

Emphysema is a severe form of Chronic Obstructive Pulmonary Disease, or COPD. Emphysema is progressive, meaning it worsens over time, and it can have a significant impact on your quality of life. It may be challenging to engage in your daily activities due to breathlessness and fatigue. You may find that you’ve become less inclined to engage socially with family and friends, and that even simple things have become difficult. When medical management, oxygen therapy, and pulmonary rehabilitation no longer provide sufficient relief, surgery and lung transplantation have been the only alternatives, until now.

Endobronchial valve therapy with the Spiration Valve System (SVS) offers a new, minimally-invasive treatment option for severe emphysema patients. For appropriate patients, SVS has been shown in clinical trials to provide clinically meaningful improvements in lung function, shortness of breath, and overall quality of life.

SPIRATION VALVE SYSTEM

The Spiration Valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of the diseased lung. The Spiration Valve system redirects the air you breathe away from the areas most affected by your emphysema and toward the healthier areas of your lungs allowing you to breathe more easily.

Small Anchors

Lightly grips airway to help the valve stay in place

Umbrella Design

Redirects the air you breathe in and allows air and secretions from diseased areas of the lung to escape naturally.

Removal Rod

Allows your doctor to remove the valve, if necessary.

PROCEDURE

After performing tests, your doctor will determine if you are an appropriate candidate for the Spiration Valve System. If you are a candidate, on the day of the procedure, you can expect the following:

  1. ‌
    Your doctor will give you medication that will make you sleepy (sedation) or unconscious (anesthesia). 
  2. ‌
    Using a bronchoscope (a thin tube with a camera, inserted through your mouth or nose), your doctor will place the Spiration Valves in your airways.
  3. ‌
    You may be required to stay overnight in the hospital following your procedure so that your physician may observe you to ensure the Spiration Valves are having the desired effect.
  4. ‌
    Your doctor will give you instructions for your care at home, including which medicines you should take and any follow-up visits.

ALPHA-1 ANTITRYPSIN DEFICIENCY

Alpha-1 antitrypsin deficiency is a genetic condition and can often result in Chronic Obstructive Pulmonary Disease (COPD) and severe emphysema symptoms in patients of any age.

The Spiration Valve has been studied and shown to benefit these patients. Spiration Valve placement resulted in improvements in lung function, quality of life, and shortness of breath.1

ALPHA-1 ANTITRYPSIN DEFICIENCY

TAKING THE NEXT STEPS

If you are continuing to experience severe emphysema symptoms, despite medical management and pulmonary rehabilitation, it may be time to ask your doctor about the Spiration Valve System procedure. Potential benefits and risks of endobronchial valve therapy with the Spiration Valve System can be found below.

Potential Benefits

Spiration Valves reduce the volume of diseased parts of the lung, and redirect air to healthier parts. This may help improve overall lung function and quality of life for people living with emphysema.

In a recent clinical study with the Spiration Valve System, many of the treated patients experienced the following benefits:

  • Improved ability to breathe
  • Reduction in air trapped in their lung
  • Decreased shortness of breath
  • Increased ability to perform daily activities
  • Improved quality of life

Some patients reported immediate benefits from treatment, but it can sometimes take several months to achieve maximum effect.

Potential Benefits

Potential Risks

Potential Risks

Valve therapy is a minimally invasive procedure that is well tolerated by most patients, but is not without risks. Please discuss the potential risks with your doctor. Potential complications which may be associated with bronchoscopy and/or the Spiration Valve System may include, but are not limited to, pneumothorax, worsening of COPD symptoms, hemoptysis, pneumonia, dyspnea, and in rare cases, death.2

Frequently Asked Questions

Will I be able to feel the Spiration Valve in my lung?

No, you will not be able to feel the Spiration Valve after it’s been placed in your lung.

How long will the procedure take?

The bronchoscopy procedure used to place the Spiration Valve usually takes less than one hour but may take up to two hours.

When will I feel better after procedure?

The amount of time that it takes to feel better after your procedure varies from patient to patient. You should discuss how you are feeling regularly with your doctor.

Can it be coughed out?

In Spiration Valve clinical trials, no patients have coughed out a Spiration Valve However, in a rare case, a valve may be coughed out.

Will I be able to stop or decrease using my oxygen and other COPD medications?

Although you may feel better after receiving the Spiration Valves, always consult your doctor before you make any changes to using oxygen and COPD medications. Valve therapy is not a substitute for treatment of COPD by medication or oxygen therapy.

How long will it stay implanted in me? Is the procedure reversible?

The Spiration Valve is intended to be permanent, however it’s designed to allow removal, if necessary.

How many valves will the doctor place in me?

Every person’s lungs are different. On average, four Spiration Valves are implanted per procedure.

Does the doctor ever need to go back to check on them?

Yes. As part of your regular follow-up visits with your doctor (pulmonologist), they will examine the effect of the valve therapy. Your doctor may want to inspect your valves using a bronchoscope.

What happens when I go through security at the airport?

The Spiration Valve will not set off the metal detectors used by airport security.

What is the expected length of recovery from the procedure? When can I go back to normal activities?

Although you may feel much better after the procedure, it’s very important to allow your lungs to adjust to the recent procedure so that you don’t suffer any setbacks. Follow your doctor’s instructions, including any plans to rest and limit activity after the procedure.

1. Criner GJ, Delage A, Voelker K. Late Breaking Abstract - Endobronchial Valves for Severe Emphysema – 12-month Results of the EMPROVE Trial. Eur Respir J. 2018;52(suppl 62). doi:10.1183/13993003.congress-2018.OA4928

2. Hogarth DK, Delage A, Zgoda MA, Reed MF. American Thoracic Society International Conference Abstracts. American Thoracic Society; 2018:A7754-A7754. doi:10.1164/ajrccm-conference.2018.197.1_MeetingAbstracts.A775

Spiration is a registered trademark of Olympus Respiratory America.

Patients and Family