Posted: 2013-03-20 in Press Releases
Osprey Medical Inc. announces enrolment of first patient in the CINCOR IDE Clinical Study
• Osprey Medical has commenced its US registration directed pivotal IDE clinical study of the CINCOR™ system which is expected to show a significant reduction in Contrast Induced Nephropathy (CIN), a form of acute kidney injury, in patients undergoing common heart procedures.
• The CINCOR dye reduction and removal system limits the amount of dye used in a heart procedure from reaching the kidneys, thereby reducing the risk of CIN.
• The multi country trial will be conducted in 30 hospitals enrolling 600 patients with complete enrolment and FDA submission expected in 2014.
• Since receiving FDA clearance in December 2012 to add the company’s dye reduction technology to the FDA registration directed trial, the company already has a number of US hospitals at advanced stage of approval for participation in the trial, with 4 hospitals (3 US and 1 Germany) now fully approved and recruiting patients.
Minnesota, United States and Melbourne, Australia - March 20, 2013 - Osprey Medical Inc. (ASX: OSP) today announced enrolment of the first patient in the CINCOR IDE Clinical Study at the Leipzig Heart Centre in Germany.
Dye is routinely used to 'x-ray' heart tissue during coronary angiography and stenting procedures, but it can cause serious and irreversible damage to the kidneys. The CINCOR System is designed to provide cardiologists with an advance level of protection against this damage known as Contrast Induced Nephropathy (CIN) in high-risk patients undergoing coronary angiography and stenting procedures. The CINCOR System is a dye reduction and removal system that both reduces the amount of dye injected and removes a significant quantity of any dye used as it leaves the coronary sinus (the heart's main drainage vein) before reaching the kidney. At present there is no effective way for cardiologists to prevent the dye from reaching the kidneys.
The registration directed IDE pivotal trial will enrol 600 patients in 30 centres around the world. The trial results will support a US FDA 510(k) regulatory submission which is expected in late 2014.
The first patient was enrolled by Dr Steffen Desch at the Leipzig Heart Centre in Leipzig, Germany. Dr Desch commented: “Osprey’s CINCOR system, with its ability to reduce and remove contrast dye, has the potential to offer chronic kidney disease patients undergoing a coronary angiogram a lower risk of CIN.”
Approximately 25% of all patients undergoing coronary angiography and stenting procedures are at high risk of acquiring CIN due to their pre-existing kidney disease. CIN can have a significant impact on patients’ lives, which can result in longer hospitalisation, reduced kidney function, increased risk of heart disease, total kidney shut down and significant increase in likelihood of death.
As part of the trial in the US< Osprey Medical will also be collecting health economic data on patients for 12 months after the procedure. This data is not required for the US regulatory approval, but will be useful for marketing CINCOR by demonstrating longer term economic outcomes to hospitals and payers.
Not only may patients benefit from the CINCOR System, but hospitals and payers are also motivated to reduce the incidence of CIN. Osprey Medical President and CEO, Mike McCormick said: “Patients who develop CIN generally require an average f four days of additional hospitilisation, often in an intensive care unit. These additional services cn cost hospitals up to $4,000 er day. These costs are generally borne by the hospital, and are usually not reimbursed by insurers.”
About Contrast Induced Nephropathy (CIN)
Contrast Induced Nephropathy (CIN) is a form of kidney damage caused by the toxic effects of dyes (contrast) used by cardiologists to xray the heart and blood vessels during commonly performed heart procedures such as angioplasty and stenting. The dye is toxic and can reduce the blood flow in kidneys, which can lead to kidney cell death and serious patient complications.
About CINCOR System
The CINCOR System is designed to provide cardiologists with an advanced level of CIN protection in high risk patients undergoing heart procedures such as coronary angiography and stenting procedures. The CINCOR System is a dye reduction and removal system. When dye is injected for heart procedures, there is often a significant general leakage of the dye, due to a process termed “reflux”. The CINCOR system limits reflux; thereby, reducing the amount of dye injected into the patient. In addition, the CINCOR system captures and removes a significant quantity of dye that is used during the heart procedure as it leaves the coronary sinus (the heart’s main drainage vein) before it makes its way to the kidneys.
Key CINCOR System Objectives:
• Reduce and remove toxic dye used in heart procedures
• Save patient’s lives
• Improve patient outcomes
• Provide opportunity for best patient care
• Save money for hospitals and payers
• Become the accepted standard of care for CIN prevention
• Europe – CE Mark obtained for the CINCOR Contrast Removal System and for the Reflux Reduction System
• Australia – Exclusively for Clinical Investigation
• United States – CAUTION Investigative device, limited by Federal (or United States) law to investigational use