Medtronic reports positive NAVIGATE ENB study data

31 January 2019 (Last Updated January 31st, 2019 12:40)

Medtronic has reported positive results from the NAVIGATE study conducted to assess the use of electromagnetic navigation bronchoscopy (ENB) procedures guided by the company’s superDimension navigation system.

Medtronic has reported positive results from the NAVIGATE study conducted to assess the use of electromagnetic navigation bronchoscopy (ENB) procedures guided by the company’s superDimension navigation system.

ENB is intended to enable lung cancer diagnosis, staging and preparation for future treatment via a single procedure. It offers a minimally invasive method to access difficult-to-reach lung areas and detect the presence of disease.

The prospective, multi-centre NAVIGATE study was conducted at 37 sites in the US and Europe. Its 12-month follow-up data, published in the Journal of Thoracic Oncology, involved 1,215 US patients.

“The ENB procedure was successfully completed in 94% of participants and an ENB-aided diagnosis was obtained in 73%.”

Findings covered the proportion of patients receiving an ENB-aided diagnosis (diagnostic yield), supported by follow up.

The ENB procedure was successfully completed in 94% of participants and an ENB-aided diagnosis was obtained in 73%.

It was observed that the diagnostic yield with ENB was consistent and generalisable across operators, compared to 65-73% yields in previous small, single-centre retrospective studies using various devices.

The NAVIGATE study found that 65% of patients diagnosed with primary lung cancer were at early stages (Stage I or II) of the disease.

As 49% of lesions at these stages are less than 20mm in diameter, NAVIGATE is said to confirm that ENB can be used to assess small peripheral lesions.

The procedure was also observed to have lower complication rates than transthoracic needle biopsies.

Medtronic Lung Health vice-president and general manager Emily Elswick said: “At Medtronic, we are setting the standard for clinical and economic evidence that substantiates the value of our innovative platforms for patients, providers and payers worldwide.

“Lung cancer remains the deadliest cancer and Medtronic is uniquely positioned to innovate, invent and disrupt with products and services that contribute to longer-term survival.”

The superDimension system holds approvals in several markets, including the US and European Union.

Its latest version, the superDimension Navigation System Version 7.2 with Fluoroscopic Navigation Technology, features advanced software to improve the visibility of lung lesions in real-time.