CircuLite Receives ISO 13485 Certificate of Registration For The SYNERGY Pocket Micro-Pump For Chronic Heart Failure
- Registration Marks Important Step in CE Mark Approval Pathway -
SADDLE BROOK, N.J. and AACHEN, Germany (December 12, 2008) - ISO 13485 is a regulatory certification for the international medical industry, created by the International Organization for Standardization (ISO), which defines standards for the design, development, production and distribution of medical devices, and also ensures conformity with certain quality controls in the development of safe and effective devices. This globally recognized standardization system is also a regulatory requirement for medical devices to be commercially distributed in certain international markets, and is an important step in the CE Mark regulatory process in the European Union.
"The successful completion of the ISO registration process is a significant achievement for CircuLite and an important milestone towards achieving our goal bringing the SYNERGY micro-pump to patients," said Paul Southworth, President and CEO of CircuLite. "The ISO registration reflects our commitment to the highest standards of manufacturing, quality assurance, and safety, and comes at a crucial time as we approach completion of the European registration trial for the long-term use of SYNERGY in patients with chronic heart failure and pursue CE Mark approval and the initiation of US IDE studies in 2009."
The SYNERGY™ Pocket Micro-pump represents a new approach to mechanical circulatory support that can transform chronic heart failure management by providing a less-invasive, elective treatment option for patients before their disease state becomes emergent. SYNERGY™ is the first implantable system designed to provide partial circulatory support (PCS) for long-term use in millions of unserved patients that have NYHA Class IIIb/early IV disease.
CircuLite's patented micro-pump provides up to 3L/min of flow, which increases total cardiac output and offloads the heart allowing it to rest, potentially enabling beneficial recovery of heart function. The size of a AA battery, the device is small enough to be implanted subcutaneously in a "pacemaker-like" pocket through a minimally-invasive procedure.
CircuLite is transforming heart failure treatment with the development of minimally-invasive devices for long-term partial circulatory support (PCS). By enabling a proactive and lower-risk treatment approach by supplementing a patient's native pumping capacity, CircuLite has the potential to improve the quality of life for millions of chronic heart failure patients and their families. CircuLite's pipeline of PCS devices is lead by the SYNERGY™ Pocket Micro-pump, the world's smallest implantable blood pump currently in a CE Mark clinical trial. Next-generation SYNERGY micro-pumps include an endovascular system, a fully-implantable system and a pediatric system. For more information on CircuLite and the SYNERGY Pocket Micro-pump devices, visit our website at www.CircuLite.net.
MacDougall Biomedical Communications
Gail Farnan, Vice President, Marketing
CAUTION: Investigational Device. Limited by Federal Law to Investigational Use Only.
CircuLite® is a registered trademark of CircuLite, Inc. in the United States.
SYNERGY™ is a trademark of CircuLite, Inc. in the United States.