PleuraFlow® Awarded Medical Device Excellence Award

Bend, OR—April 6, 2011—Clear Catheter Systems, Inc., today announced that the PleuraFlow® Active Tube Clearance® System has been awarded a 2011 Medical Design Excellence Award. The Medical Design Excellence Awards (MDEA) competition is the premier awards program for the medical technology community. Entries are evaluated on the basis of design and engineering features that improve healthcare delivery, change traditional medical attitudes or practices, and provide enhanced benefits to the patient.

Presentation of the 2011 Medical Design Excellence Awards will take place on Wednesday, June 8th in a ceremony at the Medical Design & Manufacturing (MD&M) East Conference and Exposition in New York City.

The PleuraFlow® is a novel chest tube clearance accessory developed to maintain chest tube patency after heart and lung surgery. Clogging of a chest tube with a clot in the setting of continued postoperative drainage can contribute to impaired patient outcomes and even death. Nurses often have to improvise to keep the tubes open by tapping, squeezing, and milking the tubes in an attempt to clear the clots in the post operative setting. This can be frustrating and time consuming and is not always successful. Chest tube clearance with the PleuraFlow® is achieved by advancing the specially designed clearance member back and forth within the chest tube under sterile conditions, breaking down and pulling clots back out of the tube, thereby leaving the inner portion of the chest tube clear of any obstructing material.

The PleuraFlow® was developed by cardiothoracic surgeons who saw a clinical problem and knew there had to be a better way. “We envisioned a system that would allow for clots to be mechanically cleared inside chest tubes without breaking the sterile field,” said cardiothoracic surgeon, company founder and CEO, Dr. Ed Boyle. Boyle teamed up with Cleveland Clinic heart surgeon Dr. Marc Gillinov to create a solution that would improve patient outcomes, give nurses a much-needed tool, and reduce patient pain in the process. Working with Carbon Design Group and Xerideim, the team created a product that features a metal loop at the end of a guide wire inside the tube. A hand piece outside the tube is connected via magnetic coupling to the guide wire. This allows the nurse to manipulate the wire by shuttling the hand piece back and forth along the along the tube without breaking the sterile field. “This configuration allows nurses to quickly clear chest tube blockages—even the unseen blockages inside the chest cavity,” said Boyle.

In a study published in the February 2011 edition of the Annals of Thoracic Surgery, investigators at the Cleveland Clinic compared drainage from a large diameter (32 French) standard chest tube and that from a smaller (20 French) PleuraFlow® Active Tube Clearance® (ATC) chest tube. “This is the first time a smaller diameter chest tube has been shown to drain better than a larger diameter chest tube,” said Dr. Gillinov, an investigator on the study. Though the PleuraFlow® is available in both the large and small diameters, the results of this study indicate that doctors may be able use the smaller PleuraFlow® to help minimize patient pain, while still delivering better drainage than the larger, standard chest tube.

In addition to the MDEA win, the PleuraFlow® received the 2009 European Association of Cardiothoracic Surgeons Techno-College Innovation Award in the worldwide competition to identify innovations with the potential to change the standard of care in heart and lung surgery.

About Clear Catheter Systems, Inc. Clear Catheter Systems is a Bend, Oregon based medical device company developing an anti-clogging platform of surgical drainage devices. Its lead product is the PleuraFlow® Active Tube Clearance® System, which addresses the problem of chest tube clogging after heart and lung surgery. In addition, Clear Catheter has a pipeline of products based on its proprietary tube clearance technology to treat tube clogging in other medical market segments, including a system for the urinary catheter drainage market, the enteral feeding sector as well as systems for standard surgical drains.

About Cleveland Clinic Innovations. Innovations, the corporate venturing arm of Cleveland Clinic, promotes innovation and is responsible for the commercialization of all Cleveland Clinic technologies. Innovations advances product-oriented innovation and transforms promising therapies, devices, diagnostics and software into beneficial medical products, via spin-off companies, licensees and equity partnerships. There have been 33 companies spun off from the Clinic in the last decade, more than 200 licenses, more than $340 million in equity investment in those spin-offs and a record number of inventions in virtually every area of activity at Cleveland Clinic. In 2010, Cleveland Clinic Innovations was named one of the Most Influential Healthcare Corporate Venturing Divisions by the Global Corporate Venturing.

### PleuraFlow® is a registered trademark of Clear Catheter Systems. Other company and product names may be trademarks of their respective owners. Media Contact Kelly Herman (541) 419-8855 kelly@kellyherman.com

 

ClearFlow's PleuraFlow® Active Clearance Technology and many of its features are protected by a comprehensive family of both US and foreign patents and patent applications in major markets throughout the world, including Canada, Australia and the European Community. In the United States, PleuraFlow® products are protected by US Patent Nos. 7,854,728, 7,951,243, 8,246,752, 8,048,233, 8,388,759 and 8,702,662. The PleuraFlow® product is the first device of its kind to effectively and reproducibly clear obstructing material from chest tubes without compromising the sterile field, and thus patient recovery. It is the only FDA 510(k) cleared device of its kind for this indication. ClearFlow's patent portfolio has been tailored not only to protect this product, but also to provide protection around this new market segment thus presenting a barrier to entry for competing products.