Internet Journal of Pulmonary Medicine
May 05, 2016
Utilizing next generation surgical navigation technology from Veran Medical, researchers from Morehouse School of Medicine and Emory University, working in the Grady Hospital Cancer Center of Excellence, have published clinical trial results demonstrating a 90.2% yield in diagnosing patients with small, suspicious peripheral nodules in their lungs. Procedures were performed on their initial 44 consecutive patients. There were no reported pneumothorax (collapsed lung) or other complications.
Limited by conventional tools, doctors have been challenged with reaching and definitively diagnosing suspicious lung nodules with published diagnostic yields ranging from 50-70%, depending on size and location of the nodule. The resulting delays and repeated procedures add increased risk to patients and unnecessary costs to the health care system.
Veran Medical’s SPiN Thoracic Navigation System utilizes proprietary Always-On Tip Tracked® instruments with tiny electromagnetic sensors on the tips to safely and accurately assist physicians in navigating to, localize, and sample hard to reach targets. Published research confirms that those nodules move when a patient is routinely breathing —creating a moving target for lung specialists and surgeons trying to reach them. Veran’s exclusive 4D dynamic respiratory technology ensures physicians can confidently and accurately reach target nodules even if a patient coughs, moves, or simply breathes in and out during the procedure.
Dr. Eric L. Flenaugh, the director of Advanced Diagnostic and Interventional Pulmonary service, performed all procedures at Grady Memorial Hospital’s Cancer Center of Excellence in Atlanta, Georgia. Grady is the fifth largest public hospital in the United States and the largest hospital in the state of Georgia.
“Without using 4D respiratory tracking, the variation in inspiration/expiration would have contributed to completely missing the target,” said Dr. Flenaugh. “While significant movement relative to the size of the nodules being targeted was measured between the inspiration and expiration state in our study, we found the SPiNDrive system to be very accurate in compensating for this motion.”
Using Veran’s technology, Dr. Flenaugh biopsied 71 lesions with 39% of them determined to be malignant. The average nodule size was 2.2cm in diameter. All lung nodules were sampled transbronchially with navigated bronchoscopic instruments (brush, forceps, steerable catheter, or needle) and/or percutaneously using Veran’s SPiNPerc platform (navigated transthoracic needle). Dr. Flenaugh also used the SPiN Thoracic Navigation System to precisely place fiducial markers in 2 patients in order to assist Radiation Oncology with lung Stereotactic Body Radiation Therapy (SBRT). The study results were published in the Internet Journal of Pulmonary Medicine (http://ispub.com/IJPM/18/1/37993).
Lung Cancer remains the number one cancer killer in the United States. 94 million current or former smokers remain at elevated risk. Results from the recent National Lung Screening Trial, which screened more than 50-thousand patients and was published in the New England Journal of Medicine, demonstrate that lung screening saves lives. New physician guidelines recommend regular patient screenings using CT scans and biopsies for nodules greater than 8mm in size (about the size of a small pea).
“Veran’s SPiN Thoracic Navigation system and SPiNPerc are transforming the physician’s ability to accurately access and diagnose hard to reach Solitary Pulmonary Nodules (SPNs) and to provide cost-effective care for the 2.7 million SPNs found annually in the US,” said Veran CEO Jason Pesterfield. “We are very excited about the results of this study. Not only does this technology allow lung specialists more ways to accurately target SPNs, but it also allows those physicians the ability to streamline the diagnostic process by incorporating two procedures into one. This ultimately saves more lives through earlier diagnosis and treatment of lung cancer.”
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.