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Apr 3rd, 2014
 
First in-human implantation of an ISSYS wireless implantable hemodynamic monitor
 
ISSYS Inc. will showcase its Titan Wireless Implantable Hemodynamic Monitor and its clinical study summary at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco.
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Integrated Sensing Systems, Inc. (ISSYS) announced that the company will exhibit its Titan Wireless Implantable Hemodynamic (IHM) Monitor system at the 25th Annual Transcatheter Cardiovascular Therapeutics Conference (TCT) (Booth 1638). ISSYS will also report a summary of the current clinical investigational study of its wireless miniature implants placed in the left atrium or left ventricle for the management of congestive heart failure (CHF) patients. ISSYS Titan IHM implant distinguishes itself by being able to monitor the left side of the heart. The left-heart pressure waveforms are the most desirable parameters for the management of patients with cardiovascular problems, in particular congestive heart failure. Monitoring the left heart is, however, very challenging due to the stringent biocompatibility and hemodynamic requirements of the left heart.

The associated clinical study is performed in collaboration with the Thoracic and Vascular Surgery Clinic at the Linkoping Hospital, in Linkoping, Sweden. The clinical principle investigators are Professor Henrik Ahn and Dr Jacek Baranowski. The aim of the study is to investigate the efficacy and safety of the Titan wireless IHM in improving short- and long-term treatment in heart failure patients. ISSYS produces its miniature wireless IHM implants at its own facility which is ISO-13485 certified.

ISSYS’ wireless IHM is intended to be implanted as an adjunct device during a planned heart surgery, minimally invasive surgery, or transcatheter delivery. Titan IHM is composed of three components; Telemetric Implant, Monitoring Unit, and Database Management for internet-based worldwide access. Dr. Nader Najafi, ISSYS President and CEO, stated that, "ISSYS IHM implants offer many practical features such as home monitoring capability and on demand wireless data capture. A custom-made internet database allows the patients to submit the home monitored cardio waveforms to the database and the medical staff to read the patient’s data at will anywhere in the world. The Titan system also allows long-term monitoring (i.e., Trending) of important parameters such as Filling Pressure.”

Company Background:
ISSYS is a leader in advanced MEMS technologies for design and manufacturing of industrial, medical, microfluidic and scientific analytical sensing applications. Founded in 1995, ISSYS is one of the oldest independent MEMS companies in the US. ISSYS operates a comprehensive, state-of-the-art MEMS fabrication facility located near Ann Arbor, Michigan. ISSYS is currently certified for ISO 9001:2008, EN13980:2002 for its ATEX (intrinsically safe products), and ISO13485:2003 standard for Class III medical devices. ISSYS is a vertically integrated company dedicated to developing and manufacturing system-level products based on MEMS technology (MEMS Inside), please visit: http://www.mems-issys.com/


 
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