{"73253":{"#nid":"73253","#data":{"type":"news","title":"New CardioMEMS Device Helps Aneurysm Patients","body":[{"value":"\u003Cp\u003EWinning a thumbs-up from the U.S. Food and Drug Administration, CardioMEMS Inc. has launched its EndoSure\u00e2\u0084\u00a2 sensor, which makes testing safer and more convenient for aneurysm patients. \n\u003C\/p\u003E\n\u003Cp\u003EBased on intellectual property from the Georgia Institute of Technology, EndoSure is the first implantable pressure sensor that combines wireless and microelectromechanical system (MEMS) technology to receive FDA clearance.\n\u003C\/p\u003E\n\u003Cp\u003E\u0022This is a significant milestone that validates our product is safe and relevant,\u0022 says David Stern, CardioMEMS\u0027 chief executive, noting that the FDA based its 510(k) clearance on results from an international clinical study involving more than 100 hospital patients in the United States as well as Brazil, Argentina and Canada.\n\u003C\/p\u003E\n\u003Cp\u003E\u003Cstrong\u003EBetter results, less hassle\u003C\/strong\u003E\n\u003C\/p\u003E\n\u003Cp\u003EOfficially known as the EndoSure Wireless AAA Pressure Measurement System, CardioMEMs\u00e2\u0084\u00a2 innovative device measures blood pressure in people who have an abdominal aortic aneurysm. Ruptures from this weakening of the lower aorta rank as the 13th leading cause of death in the United States. Although doctors can treat the bulging artery with a stent graft, stents can fail, so aneurysm patients require lifetime monitoring. \n\u003C\/p\u003E\n\u003Cp\u003EYet traditional testing methods, such as CT scans, are expensive and time-consuming. What\u0027s more, CT scans are limited in scope because they only reveal the size of an aneurysm. In contrast, the EndoSure monitors pressure inside the aneurysm sac - the most important measurement for doctors to know.  \n\u003C\/p\u003E\n\u003Cp\u003ECardioMEMS also makes testing easier for both doctors and patients. About the size of a paper clip, the EndoSure sensor is implanted along with the stent graft during endovascular repair. During checkups, patients don\u0027t need to remove clothing: Doctors merely wave an antenna in front of the patient\u0027s chest, and low-power radio-frequency waves activate the EndoSure system, relaying pressure measurements to an external receiver and monitor.\n\u003C\/p\u003E\n\u003Cp\u003E\u0022Initial demand is extremely encouraging, and we\u0027re working hard to get the product out to our new customers,\u0022 says Stern, noting that EndoSure is compatible with all commercially available stents.\n\u003C\/p\u003E\n\u003Cp\u003EIn addition to FDA clearance, CardioMEMS achieved another milestone when it closed on $16 million in financing in December. Leading this Series C round was new investor Medtronic, a Minneapolis-based manufacturer of implantable biomedical devices. Several previous investors also participated in the financing: Boston Millennia Partners, Foundation Medical Partners, Arboretum Ventures, Guidant Corp. and Johnson \u0026amp; Johnson Development Corp. \n\u003C\/p\u003E\n\u003Cp\u003EOutside investment in CardioMEMS now totals about $32 million - no small achievement. In fact, the company was tapped as one of the Georgia Biomedical Partnership\u0027s \u0022Deal of the Year\u0022 winners for 2006, an award recognizing companies that have advanced the state\u0027s bioscience industry.\n\u003C\/p\u003E\n\u003Cp\u003E\u003Cstrong\u003EDoctor-engineer duo  \u003C\/strong\u003E\n\u003C\/p\u003E\n\u003Cp\u003EObservers link CardioMEMS\u0027 success partly to its approach to commercialization. \u0022Instead of a technology looking for a home, CardioMEMS clearly identified a market need that required a technology solution,\u0022 points out Lee Herron, general manager of biosciences at the Advanced Technology Development Center  (ATDC), Georgia Tech\u0027s incubator for high-tech startups. \u0022When it comes to tech transfer at universities, it\u0027s often the other way around,\u0022 he explains.\n\u003C\/p\u003E\n\u003Cp\u003ECardioMEMS traces its roots to an unlikely duo: Dr. Jay Yadav, a cardiologist at the Cleveland Clinic Foundation and chairman of CCF Innovations, and Mark Allen, a professor in Georgia Tech\u0027s School of Electrical and Computer Engineering and director of the school\u0027s MEMS research group. \n\u003C\/p\u003E\n\u003Cp\u003EHaving previously founded AngioGuard, a company that developed the first filter to prevent emboli during surgery, Yadav was interested in applying MEMS technology to medical devices. (MEMS uses micro-machining fabrication to build electrical and mechanical systems at the micron scale -- one-millionth of a meter. Although MEMS was originally developed for the integrated circuit industry, it\u0027s an attractive platform for medical devices because mechanical, sensory and computational functions can be placed on a single chip.) \n\u003C\/p\u003E\n\u003Cp\u003EIntrigued by several of Allen\u0027s published papers on MEMS, Yadav traveled to Georgia Tech to meet the engineer. Allen had already developed microsensors that could monitor the performance of turbine engines in military aircraft, but he and Yadav believed that the technology could be adapted to measure heart and blood pressure in people.\n\u003C\/p\u003E\n\u003Cp\u003EAlthough Allen had been involved in a previous startup -- Redeon, a pioneer in micro-needle technology - CardioMEMS marked his first experience commercializing a biocompatible medical device. \u0022Developing an implantable sensor for humans has been very exciting,\u0022 Allen says. \u0022It\u0027s opened a whole new application area for me to think about where MEMS technology could go.\u0022 \n\u003C\/p\u003E\n\u003Cp\u003ECardioMEMS is already extending its core technology to other products. In the works are: \n\u003C\/p\u003E\n\u003Cp\u003E* A sensor that measures intracardiac pressure in people who suffer from congestive heart failure. After successful testing on animals, clinical trials began in February with a successful implantation in a patient\u0027s pulmonary artery in Santiago, Chile.\n\u003C\/p\u003E\n\u003Cp\u003E* A sensor that measures blood pressure in patients with thoracic aorta aneurysms. \n\u003C\/p\u003E\n\u003Cp\u003E* Devices to help hypertension patients monitor their condition at home and adjust medication. \n\u003C\/p\u003E\n\u003Cp\u003E\u003Cstrong\u003ELeveraging Georgia Tech resources\u003C\/strong\u003E\n\u003C\/p\u003E\n\u003Cp\u003EGeorgia Tech has played an important role in CardioMEMS\u0027 growth, agree its founders. \n\u003C\/p\u003E\n\u003Cp\u003EFor starters, the licensing process went smoothly, says Yadav, noting that Georgia Tech was \u0022very professional.\u0022 And having access to micromachining equipment and cleanrooms at Georgia Tech\u0027s Microelectronics Research Center (MiRC) was a critical resource, saving the company millions of dollars during prototype development. \n\u003C\/p\u003E\n\u003Cp\u003E\u0022A lot of our processes, such as photolithography and wafer bonding, have to be carried out in clean environment because even small amounts of dust could destroy the devices we\u0027re trying to make,\u0022 Allen explains. \u0022Georgia Tech\u0027s MiRC is one of the few places in the state where that kind of technology can be done.\u0022 \n\u003C\/p\u003E\n\u003Cp\u003ECardioMEMS has also benefited from the school\u0027s talent pool. A majority of the company\u0027s senior engineers are Georgia Tech graduates and many part-time workers are students from the school.\n\u003C\/p\u003E\n\u003Cp\u003EBeing a member of ATDC, Georgia Tech\u0027s incubator for high-tech startups, has also been a plus. \u0022ATDC has been very accommodating,\u0022 Yadav says. \u0022We expanded several times, and they always managed to find us space.\u0022 \n\u003C\/p\u003E\n\u003Cp\u003ELast year marked a particular growth spurt when CardioMEMS more than doubled its size, growing from about 30 to 70 employees. CardioMEMS graduated from ATDC last summer, but continues to maintain headquarters in Technology Square. The company also has lab space in the ATDC Biosciences Center. \n\u003C\/p\u003E\n\u003Cp\u003E\u0022Having our offices so close to Georgia Tech not only makes it easier for me to remain in a consulting role but also for our engineers to access university resources,\u0022 Allen observes. \n\u003C\/p\u003E\n\u003Cp\u003EAmong startups formed from university research, CardioMEMS has been one of Georgia Tech\u0027s biomedical pioneers. \u0022The fact that CardioMEMS is starting to gain traction shows how the school\u0027s investment in bioscience resources and infrastructure is starting to pay off,\u0022 says Kevin Wozniak, associate director of Georgia Tech\u0027s Office of Technology Licensing. He refers to an initiative that began in the late 1990s and paved the way for a new four-building complex as well as new partnerships such as Emtech Bio, an incubator devoted to the formation of life-science companies.\n\u003C\/p\u003E\n\u003Cp\u003EBecause life-science companies are prized for generating high-paying jobs, CardioMEMS\u0027 growth is good news for Georgia.  \n\u003C\/p\u003E\n\u003Cp\u003E\u0022I think we\u0027re helping change a misperception that there\u0027s no medical device industry in Atlanta,\u0022 Stern says. \u0022Granted, you wouldn\u0027t compare it to Minneapolis or Boston, but there are there are several other firms here and our progress creates additional visibility for that market in Atlanta. Success breeds success, helping attract more companies and investors.\u0022\n\u003C\/p\u003E\n\u003Cp\u003E\u003Cstrong\u003EResearch News \u0026amp; Publications Office\u003Cbr \/\u003E\nGeorgia Institute of Technology\u003Cbr \/\u003E\n75 Fifth Street, N.W., Suite 100\u003Cbr \/\u003E\nAtlanta, Georgia  30308  USA\u003C\/strong\u003E\n\u003C\/p\u003E\n\u003Cp\u003E\u003Cstrong\u003EMedia Relations Contact\u003C\/strong\u003E: John Toon (404-894-6986); E-mail: (\u003Ca href=\u0022mailto:jtoon@gatech.edu\u0022\u003Ejtoon@gatech.edu\u003C\/a\u003E).\n\u003C\/p\u003E\n\u003Cp\u003E\u003Cstrong\u003ETechnical Contacts\u003C\/strong\u003E: David Stern (404-920-6703); E-mail: (\u003Ca href=\u0022mailto:dstern@cardiomems.com\u0022\u003Edstern@cardiomems.com\u003C\/a\u003E) or Mark Allen (404-894-9419); E-mail: (\u003Ca href=\u0022mailto:mark.allen@ece.gatech.edu\u0022\u003Emark.allen@ece.gatech.edu\u003C\/a\u003E).\n\u003C\/p\u003E\n\u003Cp\u003E\u003Cstrong\u003EWriter\u003C\/strong\u003E: T.J. Becker\n\u003C\/p\u003E","summary":null,"format":"limited_html"}],"field_subtitle":[{"value":"Implantable wireless pressure sensor is based on Georgia Tech innovation"}],"field_summary":[{"value":"Winning a thumbs-up from the U.S. Food and Drug Administration, CardioMEMS Inc. has launched its EndoSure\u00e2\u0084\u00a2 sensor, which makes testing safer and more convenient for aneurysm patients. The device is based on intellectual property from the Georgia Institute of Technology.","format":"limited_html"}],"field_summary_sentence":[{"value":"A new medical device helps aneurysm patients"}],"uid":"27303","created_gmt":"2006-02-03 01:00:00","changed_gmt":"2016-10-08 03:03:34","author":"John Toon","boilerplate_text":"","field_publication":"","field_article_url":"","dateline":{"date":"2006-02-03T00:00:00-05:00","iso_date":"2006-02-03T00:00:00-05:00","tz":"America\/New_York"},"extras":[],"hg_media":{"73254":{"id":"73254","type":"image","title":"CardioMEMS sensor","body":null,"created":"1449177990","gmt_created":"2015-12-03 21:26:30","changed":"1475894673","gmt_changed":"2016-10-08 02:44:33"}},"media_ids":["73254"],"related_links":[{"url":"http:\/\/www.ece.gatech.edu\/faculty\/fac_profiles\/bio.php?id=4","title":"Mark Allen\\\u0027s Web site"},{"url":"http:\/\/www.atdc.org\/","title":"ATDC"},{"url":"http:\/\/www.cardiomems.com\/","title":"CardioMEMS Web site"}],"groups":[{"id":"1188","name":"Research Horizons"}],"categories":[],"keywords":[],"core_research_areas":[],"news_room_topics":[],"event_categories":[],"invited_audience":[],"affiliations":[],"classification":[],"areas_of_expertise":[],"news_and_recent_appearances":[],"phone":[],"contact":[{"value":"\u003Cstrong\u003EJohn Toon\u003C\/strong\u003E\u003Cbr \/\u003EResearch News \u0026amp; Publications Office\u003Cbr \/\u003E\u003Ca href=\u0022http:\/\/www.gatech.edu\/contact\/index.html?id=jt7\u0022\u003EContact John Toon\u003C\/a\u003E\u003Cbr \/\u003E\u003Cstrong\u003E404-894-6986\u003C\/strong\u003E","format":"limited_html"}],"email":["jtoon@gatech.edu"],"slides":[],"orientation":[],"userdata":""}}}