Feb 02, 2010
ST LOUIS, February 2, 2010 – Veran Medical Technologies announced today that it has recently received two clearances (K093146 & K093995) from the U.S. Food and Drug Administration (FDA) to expand its indications for use of the SPiN IR™ System. The addition of the Ultrasound and 3D Fluoroscopic X-ray image modalities represent an important advancement for SPiN IR™. The ability to perform navigated cancer thermal ablation in lower cost imaging suites greatly increases the access and cost effectiveness of these procedures while maintaining the high-resolution image quality provided by conventional CT guidance. “History has shown that the delivery of therapies in a cost effective, reliable, and efficient manner is as important as the therapy itself. We are excited about the near future when we will have tightly integrated therapy and delivery as well. These clearances allow Veran to be a market unlocking key in driving the growth of minimally invasive interventional oncology procedures.” said Les Carlson, Veran Director of Percutaneous Products.
Veran is a privately held medical device company headquartered in St. Louis, MO. The company’s main focus is assisting physicians in the early diagnosis and treatment of lung cancer. 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 and CE Mark 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.
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