Oct 30, 2019
October 30th, 2019 – St. Louis, MO
Physician Primary Investigator, Dr. Faiz Bhora, has successfully completed the first electromagnetic navigation procedure in the Veran Medical sponsored ‘PLOTS’ clinical registry focused on the localization of small peripheral pulmonary nodules for lung resection surgeries.
The study is titled “Intraoperative, Percutaneous Localization of Peripheral Pulmonary Nodules for Resection: a Prospective, Open-Label, Multi-Center Registry Study of Thoracic Surgery Outcomes.”
Investigators from approximately 10 U.S. medical centers will enroll 100 patients and utilize the SPiN Thoracic Navigation System™ for the intraoperative percutaneous localization of peripheral pulmonary nodules (PPNs), in order to identify and promulgate efficient, evidence-based best practices for this technique. This method of electromagnetic pulmonary nodule localization percutaneously in the OR, immediately prior to surgical resection, is only available with the SPiN Thoracic Navigation System™.
Successful localization of small PPNs that are consistent with early stage lung cancer is a challenge involving multiple factors, beginning with the subjects’ health, lung function, and surgical risk. Also, there are many factors specific to the nodule, including location within the lung, size of nodule, distance from the lung surface, whether there is solid or ground glass opacity, and proximity to a fissure. Difficult to see or palpate nodules are currently localized with dye and/or hook wires or fiducials, either endoscopically or by interventional radiology.
Successful, multicenter prospective studies have not been reported evaluating modern electromagnetic navigation (EMN)-guided percutaneous intraoperative localization methods combined with different techniques (dye vs. fiducial vs. hook wire, etc.). This multi-center registry will collect data for patients having a suspicious pulmonary nodule who undergo percutaneous intraoperative localization and immediate resection. Technical information gained from the nodule localization methods used, and surgical removal are aimed at evolving evidence-based localization standards for thoracic surgeons.
“Intraoperative identification of suspicious pulmonary nodules has been a challenge that Thoracic Surgeons have faced for many years,” said Primary Investigator, Dr. Faiz Bhora. In order to perform the most minimally-invasive procedure, localization is needed to help identify and remove these very small nodules. We are excited to have completed the first procedure in this study, and we look forward to the first of its kind, clinical data that this prospective registry will produce.”
Lung cancer remains the leading cause of cancer deaths in both men and women, in large part because it is often detected too late. Suspicious pulmonary nodules often represent early stage lung cancer with a much higher likelihood of survival if they can be diagnosed and surgically removed. However, these small nodules also tend to be very difficult to identify in thoracic surgery. Veran’s technology for localization of these small nodules allows physicians to accurately and precisely mark the nodule right before surgery to aid in the identification of the nodule being removed. This allows a lung cancer patient to be diagnosed and treated at an earlier stage of cancer, ultimately increasing their chance of survival.
“With lung cancer screening, there is a great opportunity to stage-shift lung cancer and ultimately to save lives,” said CEO of Veran Medical, Jason Pesterfield. “With this opportunity comes the challenge of identifying smaller and smaller suspicious nodules and resecting them in a minimally-invasive fashion to preserve as much healthy lung tissue as possible. Veran is excited to have a unique technology that addresses this unmet clinical need, and we look forward to this study providing the first prospective multicenter data.”
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, which will be used in this study, provides physicians the ability to use a navigated percutaneous approach to reach and mark small nodules outside of airways. The study design and list of participating sites and study investigators can be found on ClinicalTrials.gov.
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.