Navigation Links
superDimension Receives FDA 510(k) Clearance for Marker Delivery Kit

MINNEAPOLIS, April 4, 2011 /PRNewswire/ -- superDimension, Ltd. ®, a privately-owned company that develops minimally invasive interventional pulmonology devices, today announced it has received FDA 510(k) clearance for the superDimension marker delivery kit. The kit is designed for use with the Company's Electromagnetic Navigational Bronchoscopy (ENB) system, which has treated a total of 20,000 total patients since commercial launch.

David S. Wilson, MD, Columbus Regional Hospital, said, "This kit will enable both pulmonologists and surgeons  to place radiosurgical markers deep in the lungs, facilitating the treatment of early stage lung cancer through external beam radiation and minimally invasive video assisted surgeries.  This is an exciting time in the diagnosis and treatment of early stage lung cancer.  The preliminary results of the National Lung Screening Trial (NLST), combined with the ability that superDimension gives us to access the deep lungs, has changed the game for diagnosis and treatment of early stage lung cancer."  

ENB is a minimally invasive procedure, where a catheter is inserted through the throat and uses Global Positioning System (GPS)-like technology to biopsy lung lesions and lymph nodes all in one outpatient procedure. ENB provides a three-dimensional virtual "roadmap" of the lungs that enables a physician to maneuver catheters through multiple branches of the bronchial tree, extending beyond the capabilities of the traditional bronchoscope to distant, previously inaccessible regions of the lungs.  If the targeted lesions are determined to be cancerous, the physician can use ENB to place radiosurgical markers in and around lung tumors (lesions) to help radiation oncologists treat patients with external beam radiation. These radiosurgical markers can also be enhanced with dye injected markers that facilitate a minimally invasive surgical procedure.  The outpatient procedure typically leaves the patient with no more than a sore throat.  ENB has been performed on over 20,000 patients in over 320 hospitals worldwide.

Previously, the "gold standard" to diagnose lung cancer consisted of two invasive surgeries:  wedge thoracotomy (open chest partial lung removal) to biopsy the lung and mediastinoscopy (invasive lymph node surgery) to biopsy the lymph nodes.  Patients with poor lung function who could not tolerate these more invasive procedures were left with "watchful waiting" as their only option.  

About Lung CancerAccording to the Centers for Disease Control (CDC), "Lung cancer is the leading cause of cancer deaths in the United States, causing more deaths than breast cancer, prostate cancer and colon cancer combined.  Each year, approximately 200,000 patients are newly diagnosed with lung cancer in the United States and an additional 160,000 patients die from the disease."  Over one million patients die worldwide from lung cancer every year.  The World Health Organization estimates that worldwide lung cancer deaths surpassed heart disease in 2010.  The company notes, this is in addition to the millions of patients who are currently on watchful waiting with an undiagnosed spot on their lung.

For more information about lung cancer and its diagnosis, please visit

About superDimensionsuperDimension, Inc. is a Minneapolis-based, privately held company that develops and markets catheter based devices for use in the minimally invasive diagnosis and treatment of early stage lung cancer and other diseases, using the patient's natural airways to avoid surgery.  For more information, please visit

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are necessarily estimates reflecting the best judgment of our management and involve a number of risks and uncertainties that could cause actual results to differ materially from those suggested by the forward-looking statements. These forward-looking statements should, therefore, be considered in light of various important factors, including the following: the impact of the global economic recession and tight credit market and related impact on health care spending; recently enacted health care reform legislation in the United States and its implications on hospital spending, reimbursement and fees which will be levied on certain medical device companies; timing and success of product development and market acceptance of developed products; regulatory approvals, clearances and restrictions; guidelines and recommendations in the health care and patient communities; intellectual property positions and litigation; competition in the medical device industry and in the specific markets in which superDimension operates; unanticipated manufacturing disruptions; delays in regulatory approvals of new manufacturing facilities or the inability to meet demand for products; the results of the year end audit and the other factors. Statements concerning forecasts, revenue growth, procedure growth, future financial results, and statements using words such as "estimate'', "project'', "plan'', "intend'', "expect'', "anticipate'', "believe'' and similar expressions are intended to identify forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. We undertake no obligation to publicly update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events. COMPANY CONTACTS:

Media and Investor Contacts:superDimension, Inc.The Ruth GroupDan Sullivan

President and CEO

763-210-4000Rick Buchholz

Chief Financial Officer


Eric Reiss (Media)

646-536-7032 Nick Laudico (investors)


SOURCE superDimension, Ltd.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. superDimension Launches Second Generation iLogic(TM)Electromagnetic Navigation Bronchoscopy System to Detect and Diagnose Lung Cancer
2. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
3. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
4. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
5. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
6. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
7. CryoCor Receives FDA Approval for Right Atrial Flutter
8. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
9. Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
10. Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
11. Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma
Post Your Comments:
(Date:11/26/2015)... 2015 ... the  "2016 Future Horizons and Growth ... Marker Testing Market: Supplier Shares, Competitive ... offering.  --> ) ... "2016 Future Horizons and Growth Strategies ...
(Date:11/25/2015)... 25, 2015  The American Academy of Pediatrics ... and the March of Dimes cheered today,s signature ... Infants Act of 2015 (S.799), which takes ... born exposed to drugs, such as opioids, and ... all three organizations have worked together leading advocacy ...
(Date:11/25/2015)... -- ARKRAY USA , Inc., a leader ... the accuracy of its blood glucose meter systems. Last ... and Cardiovascular Disease in Los Angeles ... 01 meter and the Assure ® Prism ... accurately measure glucose levels in blood is essential for ...
Breaking Medicine Technology:
(Date:11/28/2015)... ... , ... Pixel Film Studios is back again with ProPanel: Pulse . ... endless. Users have full control over angle of view, speed method, start point, end ... to get heads to turn. , ProPanel: Pulse offers fully customizable pulsating shape masks, ...
(Date:11/27/2015)... ... , ... The rapid speed at which Americans are aging ... is needed, especially with Alzheimer’s, dementia and other cognitive conditions becoming more prevalent. ... part of this equation: 80 percent of medical care occurs in the home, ...
(Date:11/27/2015)... ... November 27, 2015 , ... The print ... USA Today in Atlanta, Dallas, New York, Minneapolis, South Florida, with a circulation ... is distributed nationally, through a vast social media strategy and across a network ...
(Date:11/27/2015)... ... November 27, 2015 , ... A simply groundbreaking television series, "Voices ... show that delves into an array of issues that are presently affecting Americans. Dedicated ... open dialogue, this show is changing the subjects consumers focus on, one episode at ...
(Date:11/27/2015)... ... November 27, 2015 , ... Dr. Thomas Dunlap ... Inc. and Dr. Tucker Bierbaum with Emergency Medicine at St., Joseph Health ... both STEMI and Sepsis conditions present in similar ways and require time-critical intervention to ...
Breaking Medicine News(10 mins):