ELEVAIR™

Endobronchial coils system

The ELEVAIRTM System is used in conjunction with a 2.8mm working channel therapeutic bronchoscope and fluoroscopic imaging to introduce multiple Coils into the lungs using a minimally invasive approach that requires no incision.

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ElevairTM Endobronchial Coils System are minimally invasive medical implants designed for the treatment of severe emphysema with hyperinflation.

The shape-memory nitinol Coils are indicated for use in patients with homogeneous and/or heterogeneous severe emphysema to improve quality of life, lung function, and exercise capacity.

ElevairTM System is used in conjunction with a 2.8mm working channel therapeutic bronchoscope and fluoroscopic imaging to introduce multiple Coils into the lungs using a minimally invasive approach that requires no incision. When implanted in sub-segmental airways of the lung, each nitinol Coil is designed to:

  • Gather and compress damaged lung tissue
  • Re-tension the airway network
  • Reduce airway collapse and air trapping
  • Redirect air to healthier portions of the lung

The Coils are available in several sizes to accommodate various airway lengths.

FAQ

What material are Coils made of and how well is it tolerated?

The material is called nitinol. It has already been extensively tested for long-term use inside the body and is used and well-tolerated in respiratory medicine, interventional radiology and angioplasty (e.g., stents). Nitinol is an alloy of nickel and titanium1. The ELEVAIR® Endobronchial Coil System is contraindicated for use in patients with hypersensitivity or allergy to nitinol (nickel-titanium) or its constituent metals.

How long has ELEVAIR® Endobronchial Coil treatment been available?

Since 2008, ELEVAIR® Endobronchial Coils have been the subject of clinical trials. They are commercially available since 2010.

How long does the procedure take?

The minimally-invasive procedure is performed bilaterally (on both the left and right lung) and takes approximately 35 to 45 minutes per lobe of the lung. Treatment of the second lung is typically performed 1 – 3 months after the first procedure.

Can ELEVAIR® Endobronchial Coils be removed after implantation?

Coils are intended as permanent implants. While it is possible to remove single Coils, they should be removed only if medically indicated.

Can MRI (magnetic resonance imaging) be performed on patients who have PneumRx® Endobronchial Coils?

The ELEVAIR® Endobronchial Coil is MR Conditional and this information applies to the entire family of ELEVAIR®  Coils (i.e. all Coil sizes). Non-clinical testing and MRI simulations were performed to identify the worst case conditions that were used to demonstrate that the ELEVAIR® Coil is MR Conditional. A patient with this device can be scanned safely, immediately (or at any time) after placement under the following conditions:

  • Static magnetic field of 1.5- or 3-Tesla, only
  • Maximum spatial gradient magnetic field of 5,000-Gauss/cm (extrapolated) or less
  • Maximum MR system reported whole-body-averaged specific absorption rate (SAR) of 2-W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode of operation for the MR system
What if the patient is in anticoagulant therapy?

Hemoptysis is a known complication of Coil treatment and of diagnostic and interventional bronchoscopic procedures in general. In infrequent cases, fatal hemoptysis has occurred in patients who have undergone Coil treatment. As such, the use of anticoagulant drugs in patients undergoing Coil treatment should be carefully considered, as it may be associated with an increased bleeding risk.

To decrease the risk of serious pulmonary bleeding events, use of antiplatelet (e.g., aspirin, clopidogrel) or anticoagulant therapy (e.g., warfarin, NOAC’s) should be stopped for seven (7) days prior to and seven (7) days following the Coil implantation procedure, or as recommended by the pharmaceutical manufacturer.

The benefits and risks of initiation or continuing use of antiplatelet or anticoagulant medications in patients who have undergone Coil treatment should be carefully assessed.

Which prophylaxis is recommended?

A prophylactic regimen of antibiotics should be taken on the day of the procedure and for at least seven (7) days after the procedure. It is recommended that steroids be taken two (2) days before and at least seven (7) days after the procedure.

Which preliminary medical examinations are necessary?

In addition to usual diagnostic tests, such as medical history and lung function, an HRCT is necessary and a QCT densitometry analysis should be considered to further support treatment planning.

CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France. 2020 Copyright © Boston Scientific Corporation or its affiliates. All rights reserved. 93-204   
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