BioCardia Announces CE Mark Approval of the First Stand-alone Intramyocardial Stem Cell Delivery Catheter System
San Carlos, CA -
November 18, 2010
BioCardia, Inc., a leader in the development of devices for the delivery of biologic therapies for the treatment of heart failure and chronic myocardial ischemia announced today its receipt of CE Mark approval for its BioCardia® Helical Infusion System.
The Helical™ Infusion System is now the first commercially available device system which enables non-surgical intramyocardial cell, gene, and protein therapy options for patients suffering from the effects of heart failure and chronic myocardial ischemia which can be used in any standard catheterization laboratory without specialized equipment. The Helical Infusion System is a two catheter system which includes BioCardia’s FDA cleared Morph® Universal Deflectable Guide catheter and the Helical Infusion Catheter. Each has received CE Mark approval.
The Helical Infusion System was developed to enable routine clinical use for biointerventional therapies. The two catheters provide highly intuitive control of three degrees of freedom for optimal positioning within the heart as well as helical needle fixation which stabilizes the location of the device in the beating heart. Combined, these and other features help maximize safety and efficiency of delivery to the myocardium.
Heart failure is a condition that can result from any structural or functional cardiac disorder that weakens or damages the heart and impairs its ability to fill with blood or pump a sufficient amount of blood throughout the body. Those over 40 years of age have a 1 in 5 chance of developing heart failure and there is a 20% mortality rate at 2 years which increases to 50% at 5 years. Myocardial ischemia affects an even larger patient population, results from poor blood flow to the heart muscle, and often results in heart failure.
BioCardia plans to work with leading hospitals and physicians across Europe to enable physicians to gain access to this new technology and provide new therapeutic options for their patients.
"The progress we have made, notably the milestones achieved in clinical results, and receiving CE Mark approval, are important as we move toward commercialization in Europe and the U.S.," said Peter Altman, president and chief executive officer of BioCardia. "We believe the Helical Infusion System will benefit patients who currently suffer from the serious effects of heart failure and chronic myocardial ischemia, many of which have no therapeutic options today.
BioCardia, Inc. (San Carlos, Calif.) was incorporated in 2002 to design, develop, manufacture, and market innovate devices to enable percutaneous delivery of biologics to treat cardiovascular disease. The company's initial products are intended to provide a new therapeutic option for patients with heart failure and chronic myocardial ischemia.