SHIELD I Trial Results Confirm St. Jude Medical HeartMate PHP Cardiac Assist Device Provides Consistent, Reliable Cardiac Support During High-Risk PCI Procedures
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced results from the SHIELD I (Coronary InterventionS in HIgh-Risk PatiEnts Using a Novel Percutaneous Left Ventricular Support Device) study that confirm the benefits of the HeartMate PHP™ (Percutaneous Heart Pump) cardiac assist device for patients undergoing high-risk percutaneous coronary intervention (PCI), a procedure to restore blood flow to the heart. The study demonstrated that consistent, stable hemodynamics were maintained during revascularization when assisted by the HeartMate PHP cardiac assist device.
SHIELD I is a prospective, nonrandomized, open-label, multicenter trial that evaluated the use of the HeartMate PHP cardiac assist device in patients who required hemodynamic (circulatory) support during complex PCI procedures. The study results from the first 46 patients were presented at the 27th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation in San Francisco, Calif.
“We are excited to share the results of SHIELD I, which support the safety and performance of the HeartMate PHP device,” said Dr. Dariusz Dudek, principal investigator of the SHIELD I study and Physician in Chief, Department of Cardiology and Cardiovascular Interventions at the University Hospital in Krakow, Poland. “The data from SHIELD I demonstrate that the HeartMate PHP device is a highly promising technology that should be considered for high-risk patients, such as those with advanced heart failure or who may be at risk of cardiogenic shock, undergoing PCI procedures.”
During a PCI procedure, the heart experiences interruptions to blood flow. The minimally invasive HeartMate PHP cardiac assist device is placed via catheter to temporarily assist circulation by continuously pumping blood during PCI, providing physicians more options for high-risk patients. Unlike traditional catheter-based support devices, the HeartMate PHP cardiac assist device can generate an average blood flow of four to five liters per minute, which is the normal amount of blood pumped out by the left ventricle.
Data from SHIELD I show the trial met both endpoints for primary performance (freedom from hemodynamic compromise during PCI) and safety (a composite of major adverse events). In addition, data from SHIELD I showed:
- Low complication rates. Researchers leading SHIELD I did not observe any cases of device- related cardiac death or myocardial infarction, no intraprocedural hypotension, and the overall incidence of complications related to the HeartMate PHP device was low
- Ease of use. The research team highlighted the consistent and efficient implantation process offered by the HeartMate PHP device
“Globally, there’s a significant opportunity for patients to benefit from cardiovascular pumps that address an otherwise unmet clinical need for complete circulatory support during high-risk PCI procedures,” said Mark Carlson, M.D., chief medical officer for St. Jude Medical. “The SHIELD I study results demonstrate the consistent and reliable circulatory support offered by the HeartMate PHP cardiac assist device, which was designed as a novel advancement to traditional catheter-based support devices.”
The HeartMate PHP device is CE Mark approved and commercially available in Europe. Approval was based on data from the first 30 patients enrolled in the HeartMate PHP SHIELD I CE Mark Trial. In the United States, the HeartMate PHP cardiac assist device is currently being evaluated in the SHIELD II IDE clinical trial as an investigational device and limited by U.S. law to investigational use.
About HeartMate PHP Cardiac Assist Device
HeartMate PHP cardiac assist device is a coronary pump designed to provide consistent circulatory support for high-risk patients undergoing PCI (percutaneous coronary intervention), a procedure to restore blood flow to the heart. The minimally invasive HeartMate PHP device can generate an average blood flow of four to five liters per minute, which is the normal amount of blood pumped out by the left ventricle.
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer dedicated to transforming the treatment of some of the world’s most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. With the recent acquisition of Thoratec, St. Jude Medical now offers the most comprehensive portfolio of products for the management and treatment of heart failure. For more information, please visit sjm.com or follow us on Twitter @SJM_Media .
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended January 3, 2015 and Quarterly Report on Form 10-Q for the fiscal quarter ended July 4, 2015. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
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