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FDA Clearance for Liver Navigation System by CASination AG on May 9, 2015 • 2:10 pm  
CAScination Announces FDA Clearance of its Navigation System for Liver Surgery
CAS-ONE LIVER is used for precise and focused treatment of liver cancer and metastasis through navigated tumor resection and navigated ablation.
Bern, SWITZERLAND (May 8, 2015) – CAScination AG, a Swiss medical device company, announces FDA 510(k) clearance of its unique, award-winning surgical navigation system for open liver surgery. Being a pioneer in surgical navigation for soft organs, CAScination guides surgical instruments for effective tumor removal while sparing healthy parts of the liver. The CAS-ONE LIVER device (CE marked since 2010) is in active use in leading European cancer centers and has enhanced treatments for hundreds of patients.
CAScination’s highly intuitive surgical navigation system with unique ultrasound fusion technology offers guidance for a wide range of surgical instruments and ablation devices. It provides surgeons with a clinically relevant tool to target small tumors and to identify structures at risk. This enables treatment of complex and advanced liver disease where high tumor load and critical tumor location demand a sophisticated surgical technique.
CAS-ONE LIVER uses world-leading surgery planning provided by CAScination’s partner MeVis Medical Solutions and enables fusion with intra-operative ultrasound imaging. Using infrared-based instrument tracking, the position and orientation of surgical instruments relative to internal anatomy is calculated and displayed in real time alongside a virtual 3D representation of the patient’s anatomy. This guides surgeons to relevant treatment locations and provides an accurate overview of the anatomical situation.
The FDA 510(k) clearance of CAS-One LIVER enables deployment of CAScination’s solution to the US where over 80’000 patients are diagnosed with primary and secondary liver cancer each year.
Matthias Peterhans, co-founder and CEO of CAScination, stated: “Our navigation solution has demonstrated its potential to enable new treatments for patients affected with liver cancer. We are pioneers in making navigation technology available for surgery on soft organs and believe that our products will lead to less invasive, more focused and less expensive management of the most relevant cancer diseases. Having attained FDA clearance, we are confident that CAS-ONE LIVER will become the new standard for effective liver cancer treatment”.
More detailed information about CAS-ONE LIVER, including the technology, product specifications and clinical experience, is available at www.cascination.com
About CAScination
CAScination is a privately held medical device company founded in 2009 as a spin-off from the ARTORG Center of the University of Bern.
The company specializes in surgical navigation technology for soft organs and currently provides a portfolio of navigation solutions for surgical and radiological cancer treatments. Its products CAS-ONE LIVER and CAS-ONE IR are CE cleared and in use at European hospitals. With the FDA clearance of CAS-ONE LIVER, the U.S. market launch is scheduled in 2015.
The company has won several awards including the CTI Swiss Medtech Award 2013, is ranked in the top 100 Swiss startups, and is currently in the finals of the Swiss Economic Award 2015.
More information is available at www.cascination.com
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发表于 2015-5-24 22:05