PleuraFlow® takes home GOOD DESIGN™ Award

January 24, 2012

PleuraFlow® has been recognized with a 2011 GOOD DESIGN™ award in the Medical category. Founded in 1950, The GOOD DESIGN™ award is one of the world’s most prestigious international awards program for new industrial design.  PleuraFlow® was selected from over 500 product designs from over 38 nations. This award comes to the company via its collaboration with Carbon Design, which helped design the PleuraFlow® Active Tube Clearance® System.

Read more:

http://www.dexigner.com/news/24548

http://chi-athenaeum.org/gdesign/2011/medical/348.html

 

Clear Catheter Systems Raises $4 Million in VC Funding

December 29, 2011

BEND, Ore., — Clear Catheter Systems, Inc., a leading developer of medical devices used in post surgical recovery announced that it has closed its first institutional round of financing. The $4 million round was co-led by Aphelion Capital and California Technology Ventures. Also participating in the financing was Research Corporation Technologies. Ned Scheetz, of Aphelion Capital and Alex Suh, of California Technology Ventures will join the board of directors. Clear Catheter Systems will utilize the capital from the latest round to respond to increasing demand for its lead product, the PleuraFlow® Active Tube Clearance® System, and drive commercialization in the United States and abroad.

“This investment is a great vote of confidence in Clear Catheter’s mission to deliver technology that will improve post surgical outcomes and reduce healthcare costs,” said Clear Catheter’s CEO, Ed Boyle. “These investors have significant experience working with high-growth medical device companies like ours, and we’re thrilled to have Ned and Alex joining the team.”

“Clear Catheter’s Active Tube Clearance® System is a groundbreaking technology to aid in the post operative recovery from surgery,” said Ned Scheetz. “We believe Clear Catheter’s PlueraFlow® system can improve hospital profitability by reducing the high costs associated with post surgical complications, and simultaneously improve patient care.”

 

PleuraFlow® recognized with a 2011 Spark:Pro Award

October 10, 2011

PleuraFlow® has been recognized with a 2011 Spark Award.

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The winners of the 2011 Spark:Pro Awards were selected this week by a jury of experts from design media, and education. Encompassing a spectrum of categories including architecture, graphic design, branding, and product design, the Spark Awards recognize design’s ability to act as a catalyst, address problems, and improve lives.

Winning a Bronze award, the PleuraFlow® Active Tube Clearance® System is the first chest tube with a mechanism for actively clearing blood clots. After heart or lung surgery, chest tubes are installed to drain fluids and air. Unfortunately, these tubes routinely clog with blood clots and debris putting the patient at risk for potentially fatal complications. With PleuraFlow®, a guide sleeve outside the tube is connected via magnetic coupling to the internal guide wire. This allows the nurse to manipulate the wire by shuttling the guide sleeve back and forth along the tube. This configuration enables nurses to prevent blockages by quickly clearing debris build-up—even the unseen build-up inside the chest cavity—without breaking the sterile field. Designed and developed for Clear Catheter Systems and manufactured by Xeridiem, PleuraFlow® delivers better patient outcomes while reducing pain due to traditional, marginally-effective, clot-clearing methods.

Spark winners, media, and design fans will gather October 21st at the Autodesk Gallery in San Francisco for a celebration and exhibition. The Spark winners will also be showcased in Guangzhou Design Week, one of the largest, most influential and comprehensive international design festivals in China. Winning designs will also be featured in Spark’s first annual yearbook being created by world-famous designer Kit Hinricks of Studio Hinrichs.

Small Device Brings Big Comfort to Post-Surgical Patients

September 23, 2011

By: Charles Murray, Senior Techincal Editor, Electronics & Test for Design News

Recovery from heart and lung surgery may one day be more tolerable for hundreds of thousands of patients, thanks to a pair of surgeons and two engineering teams who developed a device that clears chest tube clogs.

The device, shown at Design & Manufacturing Midwest in Chicago this week, changes the recovery process by eliminating the need for nurses and doctors to jockey a patient’s chest tube around in order to loosen clogs caused by coagulated blood and other fluids.

“With this, there’s now a way to unclog the chest tube without disturbing the patient,” noted Karl Sprague, project leader for Xeridiem Medical Devices, which teamed with two other companies to develop the device and its manufacturing process.

Known as the PleuraFlow® Active Tube Clearance® System, the device is an example of how a small idea can translate to big changes for patients. It consists of a Teflon-coated stainless steel wire inside a plastic (polyvinyl chloride) tube surrounded by a magnetized handle. The concentric handle, which slides along the outside of the tube, uses a neodymium magnet to move the magnetized stainless steel wire inside the tube. By moving the wire, which has a looped end, the handle enables nurses and doctors to break clogs and draw fluid through the tube, without adjusting the chest tube or pulling it out of the patient.

“Today, when a tube clogs, doctors and nurses will often pinch it with their fingers and try to create a vacuum to clear the clot,” noted Michael Cusack, director of business development for Xeridiem Medical Devices, in an interview with Design News. “But because the tube can often be inserted deep into the patient, that can be very painful.”

The PleuraFlow® device, which won a Medical Design Excellence Award from UBM Canon earlier this year, eliminates the need for insertion of multiple chest tubes (often called “garden hoses”) to help clear the fluids from the patients. Makers of the device claim they can clear the fluids through a single tube, which further reduces patient stress.

PleuraFlow® — initially designed by surgeons Ed Boyle and Marc Gillinov of the Cleveland Clinic — went through several iterations before reaching the market a year ago. Boyle and his startup company, Clear Catheter Systems Inc., worked with Carbon Design Group on the design of the device and with Xeridiem on its manufacturability. As a result, the device evolved from a slitted tube with a mechanically-connected handle to an intact solid tube that employs a magnetic coupling to move the internal wire without compromising the integrity of the tube. All of the components, including the ABS (acrylonitrile butadiene styrene) handle housing, are manufacturable in volume and FDA approved.

Sprague said that the device has thus far been used on approximately a thousand patients, but plans are for it to be applicable to many of the 2.5 million thoracic surgeries than are done in the US every year. “It’s something that could take off to the point where every cardio-thoracic surgery procedure could use this,” Sprague said.

Cusack said the device could also see use outside of thoracic surgery, such as in nasogastric tubes, feeding tubes, and urology. “Any tube that clogs can use this technology,” Cusack said.

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Clear Catheter Systems Appoints Sri Rao as Vice President of Sales and Marketing Worldwide

July 6, 2011

Clear Catheter Systems, Inc. (Bend, Oregon) is pleased to announce that they have hired a new Vice President of Sales and Marketing Worldwide, Sri Rao. Mr. Rao has 18 years of sales and management experience in the medical device field.  His focus has been almost entirely cardiac surgery, and for the last 12 years has been with start-up medical device companies specializing in introducing new products to the market.  Most recently he was in Sales Management at Estech, a cardiac surgery focused company where he managed a sales force with a focus on RF ablation, valve replacement and repair, and coronary artery bypass grafting.  Prior, Mr. Rao held Sales and Sales Management positions at ATS Medical (Acquired by Medtronic), Cryogen Inc. (Acquired by American Medical), VIA Medical, and US Surgical (now Covidien).  Mr. Rao has a Bachelor of Science degree from Purdue University, School of Engineering and Technology.

“Sri  is a consummate sales management professional, and his successful track record in building high performing sales organizations will help Clear Catheter Systems accelerate the expansion of our commercialization efforts,” said Edward Boyle, Chief Executive Officer of Clear Catheter Systems. “Particularly noteworthy is Sri’s depth of experience in introducing new medical devices over the course of his career, which makes him an ideal candidate for our organization. I am very pleased to have him join our senior management team.”

Active Chest Tube Drainage System Clears the Way for Better Patient Care

July 1, 2011

By: Shana Leonard

Cardiothoracic surgeon Edward Boyle was a man on a mission when he partnered with Cleveland Clinic heart surgeon Marc Gillinov to establish Clear Catheter Systems Inc. (Bend, OR). After years of observing clogs and blood clots form in chest tubes and their resulting adverse effects on patients, Boyle was determined to develop a solution that overcame this dangerous design flaw. Responding to this unmet clinical need, Clear Catheter has introduced the PleuraFlow® Active Tube Clearance® System to prevent chest tube occlusion and improve patient safety.

Following heart, lung, or trauma surgery, chest tubes are inserted into patients and coupled to a drainage system in order to remove excess fluid or air from the body. “A lot of what is drained is blood,” Boyle, CEO of Clear Catheter, explains. “If blood clots or coagulates in those tubes, which it tends to do, then they don’t drain very well. If that happens, it can contribute to complications and impair outcomes.” Complications resulting from clogged chest tubes can include a pneumothorax, pericardial tamponade, and excessive blood loss—the latter of which can occur if blood pools unnoticed in the chest cavity as a result of a clot formation in the portion of the tube positioned inside the body. Difficulty even arises when a clot is quickly identified in the chest tube, Boyle adds, because current methods of removal are undesirable for clinicians and may cause additional discomfort or risk for patients.

In an effort to avoid these unnecessary complications, Clear Catheter developed the PleuraFlow® system. The product consists of a standard chest tube that is inserted into the patient and then connected to a guide tube, over which is a shuttle guide set. The guide tube is then connected to a standard chest drainage system. Located within the guide tube, a guidewire featuring a distal loop moves backward and forward in the chest tube via a proprietary drive system to prevent clot formation. “We call this Active Tube Clearance®,” Boyle comments. “No other products have anything on the inside; they’re just a tube. With the PleuraFlow® system, we’re moving from passive drainage to active drainage.”

To develop the PleuraFlow® system, Clear Catheter Systems, armed with the initial concept for the clog-preventing device, sought the expertise of product development consultancy firm Carbon Design Group (Seattle) to help take the idea to the next level. Together, engineers and designers from both companies participated in brainstorm sessions to determine the optimal design of the system. “One of the most important design elements was that we had to figure out how to move the guidewire inside the tube from outside the tube,” Boyle recalls. “You can’t have an opening or a hole in the tube because that breaks the sterile barrier on the inside.”

A design epiphany came in the form of magnets, notes Robert Hubler, an industrial designer at Carbon. “There’s a magnet on the inside of the plastic tube that’s attached to the guidewire; on the outside, you have another magnet,” he explains. “The magnets will attract each other through the tube because the tube is naturally very slick on the inside and the magnet is a polished metal piece. So, it’s easy for the magnet to move on the inside of the tube with that attraction to the other magnet that’s moving back and forth without breaking the sterile barrier.” This back-and-forth movement of the guidewire in the tube serves to break up blockages, thus encouraging fluid flow and preventing coagulation.

Once the use of magnets was agreed upon, Carbon launched into the industrial design, mechanical engineering, and testing of the PleuraFlow® system based on feedback from Boyle and his surgeon colleagues. “Once Clear Catheter decided it wanted to go with the magnetic solution, we figured out a scheme for the use of the device pretty quickly,” Hubler says. “The basic architecture is that the shuttle gets released, moves back and forth, and then docks back in the home position.”

As part of the design and development process, Carbon took a close look at the forces required for the system. One challenge it faced was striking a balance so that the magnets provided enough force to drive the guidewire without interfering with nearby telemetry and other electronic systems. Achieving a balance in decoupling force also proved to be challenging. It needed to be strong enough to withstand the force of clot removal but forgiving enough to allow for separation of the wire in the shaft, if necessary, for safety reasons.

Upon finalizing the design and engineering with Carbon, Clear Catheter approached Xeridiem Medical Devices (Tucson, AZ), a company specializing in the design, development, and manufacture of complex, single-use medical devices. “We optimized the design for manufacturability,” says Mike Cusack, director of business development at Xeridiem. “We developed a manufacturing process and ensured that the device would work within the requirements of the ICU.”

Xeridiem also molded the silicone housings, and assembled, tested, packaged, and sterilized the device. The company helped with regulatory filings for the PleuraFlow® system as well. In essence, Cusack remarks, Xeridiem has served as the bricks and mortar of Clear Catheter Systems in that it manufactures the PleuraFlow® in addition to taking orders, providing technical support, answering phones, maintaining inventory, shipping for distribution, and invoicing.

Obtaining FDA approval in December, the PleuraFlow® system offers a simple solution to the common—and life-threatening—problem of chest tube clogging. And if that weren’t enough, it offers the additional benefit of enabling the use of smaller chest tubes. “Rather than using large chest tubes that look like a garden hose, our goal is to eventually be able to use a tube that is smaller and maybe only the size of a drinking straw,” Boyle says. “We think that it will not only help reduce complications, but it will also improve patient comfort.”

PleuraFlow® Captures 2011 R&D 100 Awards

June 29, 2011
The PleuraFlow® Active Tube Clearance® System has been recognized as one of the winners of the 49th Annual R&D 100 Awards, which salute the 100 most technologically significant products introduced into the marketplace over the past year. This award comes on the heels of winning a 2011 MDEA Gold award, as well as an I.D. Design Distinction recognition and the European Association of Cardiothoracic Surgeons (EACTS) Techno Innovation awards.

As the first chest tube with a mechanism for actively clearing blood clots, the PleuraFlow® Active Tube Clearance® System represents the most significant innovation in chest tubes in half a century. The PleuraFlow® Active Tube Clearance® System incorporates a metal loop at the end of a guide wire inside the tube. A guide sleeve outside the tube is connected via magnetic coupling to the guide wire. Clots can be cleared, without breaking the sterile field, by shuttling the guide sleeve back and forth along the along the tube. The device was designed and developed by Clear Catheter Systems and Carbon Design Group. Xeridiem designed and developed the manufacturing process as well as manages logistics including order fulfillment.

 

“The PleuraFlow® Active Tube Clearance® System is being used in the US, EU, and Canada to help patients recover from heart surgery safely and comfortably. “We appreciate the contribution from Carbon and Xeridiem to help us bring this product to market,” said Edward Boyle, the CEO of Clear Catheter Systems. “This award demonstrates our ability to work closely with medical innovators to bring novel products to market quickly, effectively, and on budget,” said Joseph Lee, Xeridiem’s President.

The R&D 100 Awards have long been a benchmark of excellence for industry sectors as diverse as telecommunications, high-energy physics, software, manufacturing, and biotechnology. Since 1963, the R&D 100 Awards have identified revolutionary technologies newly introduced to the market. Many of these have become household names, helping shape everyday life for many Americans. These include the flashcube (1965), the automated teller machine (1973), the halogen lamp (1974), the fax machine (1975), the liquid crystal display (1980), the Kodak Photo CD (1991), the Nicoderm anti-smoking patch (1992), Taxol anticancer drug (1993), lab on a chip (1996), and HDTV (1998).

Winners of the R&D 100 Awards are selected by an independent judging panel and the editors of R&D Magazine. The publication and its online portal serve research scientists, engineers, and other technical staff members at high tech industrial companies and public and private laboratories around the world.

Winners will be recognized at the R&D 100 Awards Banquet on Oct. 13, 2011, in Orlando, Fl. A list of winning innovations is on the R&D 100 Awards website, www.rdmag.com. Additional information, including registration for the Orlando event, will be available at that website on July 1, 2011.

PleuraFlow® Wins Medical Device Gold Award

June 21, 2011

 

Tucson, AZ (June 21, 2011)—The PleuraFlow® Active Tube Clearance® System (PleuraFlow® ATC) was honored with the Gold Medical Design Excellence Award (MDEA). The 2011 MDEA Winners Ceremony was held June 8, 2011 in conjunction with the Medical Design & Manufacturing (MD&M) East Conference and Exposition (www.MDMEast.com) in New York City’s Jacob K. Javits Convention Center.

The PleuraFlow® ATC prevents chest tube clogging after heart and lung surgery. It consists of a magnetically driven guide wire that is advanced into the PleuraFlow® Chest Tube to remove any tube obstructions or clogging. Pleuraflow® ATC was design and developed by Clear Catheter Systems, Inc, (Bend, OR) in conjunction with Carbon Design Group (Seattle, WA).  Clear Catheter Systems teamed up with Xeridiem Medical Devices (Tucson, AZ) to design and develop the manufacturing process as well as manufacture and distribute the product.

The PleuraFlow® Active Tube Clearance® System product is being used in the US, EU, and Canada to help patients recover from heart surgery safely and comfortably. “We appreciate the contribution from Carbon and Xeridiem to help us bring this product to market,” said Edward Boyle, the CEO of Clear Catheter Systems.  “This award demonstrates our ability to work closely with medical innovators to bring novel products to market quickly, effectively, and on budget,” said Joseph Lee, xeridiem’s President.

The Medical Design Excellence Awards competition (www.MDEAwards.com) is organized and presented by UBM Canon (Los Angeles) and is the only awards program that exclusively recognizes contributions and advances in the design of medical products. Entries are evaluated on the basis of their design and engineering features, including innovative use of materials, user-related functions that improve healthcare delivery and change traditional medical attitudes or practices, features that provide enhanced benefits to the patient, and the ability of the product development team to overcome design and engineering challenges so that the product meets its clinical objectives. A comprehensive review of the entries was performed by an impartial, multidisciplinary panel of third-party jurors with expertise in biomedical engineering, human factors, industrial design, medicine, and diagnostics. A select number of recipients were given the prestigious Gold designation.

About xeridiem

Xeridiem is a designer, developer and manufacturer of complex single use medical devices.  For over 25 years xeridiem has enabled major companies and venture-backed entrepreneurs to launch over 200 medical devices that have become standards of care.

Xeridiem orchestrates medical device development with an emphasis on design for manufacturability.  Our services help client’s bridges the gap between concept and commercialization.  Whether you are an established medical device company or just getting started, we offer a full menu of services designed to simplify your life.  We have a track record of on-time, on-budget project completion; no surprises. Xeridiem is backed by the financial strength of Fenner plc, the parent company and is ISO 13485:2003 certified, FDA registered.  Learn more about xeridiem at www.xeridiem.com.

 

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® Catheter, 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 and the enteral feeding sector as well as systems for standard surgical drains.

More information about Clear Catheter Systems is available at www.clearcatheter.com.

About Carbon Design Group

Carbon Design Group is a full-service product development consultancy based in Seattle, Washington. Carbon delights clients by blending insightful research, thoughtful design, and end-to-end engineering expertise. We apply informed intuition and inspired ingenuity to create stand-out products and experiences that connect. Our holistic approach minimizes risk, speeds time to market, and delivers results that resonate. Carbon is widely recognized for innovation and for the development of iconic product families. Our portfolio of clients includes GE, Intel, Medtronic, Microsoft, Panasonic, Philips, Xbox, and many more.

More information about Carbon Design Group is available at www.carbondesign.com

PleuraFlow® Featured in AATS ICU of the Future

May 5, 2011
Bend, Oregon – May 5, 2011 – Clear Catheter Systems, Inc., today announced that the PleuraFlow® Active Tube Clearance® System will be featured in the “ICU of the Future” exhibit at the annual American Association of Thoracic Surgery Meeting in Philadelphia. New for 2011, the ICU of the Future allows AATS surgeon members to view first hand what the future holds for cardiothoracic critical care. The PleuraFlow® Active Tube Clearance® System will be featured along with a wide range state-of-the-art technologies that advance the standard of care in the ICU. Chest tubes are used after every heart and lung procedure. The PleuraFlow® Active Tube Clearance® System 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 increased costs of care. Chest tube clearance with the PleuraFlow® Active Tube Clearance® System 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.
 
 

 

 

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.

PleuraFlow® Awarded Medical Device Excellence Award

April 6, 2011

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

 

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