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 PneumRx® Endobronchial Coil System is contraindicated for use in patients with hypersensitivity or allergy to nitinol (nickel-titanium) or its constituent metals.

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

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.

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

The PneumRx® Endobronchial Coil is MR Conditional and this information applies to the entire family of PneumRx®  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 PneumRx® 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

Please refer to the Instructions for Use for complete MRI information. 

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.

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.

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. 

We recommend participating in one of our workshops which take place regularly in very experienced treatment centers. Additionally, we offer trainings for endoscopy personnel and implant support from our clinical specialists.