Feb 15, 2018
February 15th, 2018 – St Louis, MO
A Multicenter Trial of Electromagnetic Bronchoscopic and Electromagnetic Transthoracic Navigational Approaches for the Biopsy of Peripheral Pulmonary Nodules (All In One) trial will use Veran’s SPiN Thoracic Navigation System™ to target small peripheral pulmonary nodules (1-3cm) with combined Navigated Bronchoscopy and Navigated Transthoracic Needle Aspiration (TTNA) approach in a single procedure.
Physician Investigators at the University of North Carolina at Chapel Hill School of Medicine have successfully completed the first electromagnetic navigation procedure in the Veran Medical sponsored ‘All In One’ clinical trial targeting small peripheral pulmonary nodules (1-3cm).
Investigators from nine US medical centers will enroll 150 patients and evaluate diagnostic yield for a novel staged diagnostic algorithm that combines Navigated Bronchoscopy and Navigated Transthoracic Needle Aspiration in a single procedure. The combined approach is designed to maximize diagnostic yield regardless of nodule size or location and is only available in Veran’s SPiN Thoracic Navigation System™.
Lung Cancer remains the leading cause of cancer deaths in both men and women because it’s often detected too late. Suspicious pulmonary nodules often represent early stage lung cancer with a much higher likelihood of survival if diagnosed early.
However, peripheral pulmonary nodules pose a greater diagnostic challenge for physicians because they are more difficult to visualize, access and biopsy. Veran’s mission is to provide physicians with the tools they need to consistently and reliably access, biopsy, and guide treatment of small nodules to stage shift cancer and save lives.
“We are very excited to participate in the first prospective multicenter trial evaluating the diagnostic yield of Veran’s SPiN Thoracic Navigation System™,” said UNC Director of Interventional Pulmonology Dr. Jason Akulian. “The fact that Veran is focusing exclusively on nodules in this clinical trial says a lot about the company’s confidence in their technology to help physicians diagnose earlier stage lung cancer patients.”
The SPiN Thoracic Navigation System™ converts CT scans into precise 3D maps used to navigate the airways in the lungs. Veran’s Always-On Tip Tracked® sampling instruments contain small electromagnetic sensors in the tips to help guide physicians to the nodules. Veran’s proprietary SPiN Perc™ technology provides physicians the ability to seamlessly transition to a navigated percutaneous approach to reach small nodules outside of airways. Overall diagnostic yield will be evaluated to assess the combination of these approaches. The study design and list of participating sites and study investigators can be found here on ClinicalTrials.gov
“Lung cancer kills an estimated 1.6 million people a year worldwide—more than any other cancer. Unfortunately, to date, the clinical evidence is clear that legacy tools just aren’t working,” said Veran Medical CEO Jason Pesterfield.
Bronchoscopy is commonly used for the diagnosis of suspicious pulmonary nodules discovered on computed tomographic (CT) imaging of the chest. However, multiple clinical trials have documented that traditional tools are failing physicians. In the large multi-center AQuIRE registry, diagnostic yields were as low as 38.5%. Results presented at the American College of Chest Physician 2017 meeting in Toronto from a randomized clinical trial pitting Radial Endobronchial Ultrasound (R-EBUS) vs. standard bronchoscopy with fluoroscopic guidance, diagnostic yields were 48.7% and 26.8%, respectively.
“Lung cancer patients and the physicians treating them deserve better odds than a flip of the coin to get a diagnosis,” said Veran CEO Jason Pesterfield. “That’s why we are investing in innovation and clinical evidence to help these doctors consistently get a proven answer and get their patients to appropriate therapy.”
Veran is a privately held medical device company headquartered in St. Louis, MO. The company’s mission is to empower physicians to diagnose cancer earlier and to enable precision therapy to save lives. In the United States, lung cancer kills more people each year than breast, prostate, pancreatic and colon cancers combined.
Veran has developed and commercialized an FDA cleared, next generation electromagnetic thoracic navigation platform called the SPiN Thoracic Navigation System®. Veran’s breakthrough technology has been adopted by leading cancer centers throughout the United States. Veran provides physicians with a full line of bronchoscopic brushes, needles, forceps and steerable catheters with tiny electromagnetic sensors embedded in the tips for precise navigation. The combination of these proprietary Always-On Tip Tracked® instruments and Veran’s exclusive patient respiratory gating technology enables physicians to accurately access lung nodules by accounting for nodule movement during patient breathing, a common challenge for lung specialists.
Another challenge lung specialists face is that approximately 40% of lung nodules lie outside of an airway, making them very difficult to reach endobronchially, and traditionally requiring an additional procedure. Veran’s SPiN Thoracic Navigation System® is the first and only FDA cleared technology that enables Pulmonologists or Thoracic Surgeons to safely and accurately access lung nodules outside of an airway using SPiN Perc®, a navigated transthoracic needle. With SPiN Perc®, Veran combines endobronchial navigation with percutaneous navigation, allowing physicians to access all lung nodules in a single procedure, regardless of nodule size or location. This eliminates the cost and risk of unnecessary procedures and empowers physicians to provide a same day diagnosis for their patients. The early diagnosis and treatment of lung cancer has been proven to save lives.