St. Jude Medical Inc. (STJ) recently revealed a new data analysis from its CHAMPION trial which was conducted to evaluate the safety and efficacy of the company’s CardioMEMS Heart Failure (HF) System for patients with New York Heart Association (NYHA) Class III HF. The new data analyzed the outcomes of a subgroup of patients with renal dysfunction (kidney failure).
Patients with heart failure also often suffer from chronic kidney disease. Medical therapies to avoid hospitalization may sometimes adversely affect renal function. Notably, the latest results from the CHAMPION trial demonstrated that monitoring the control group’s pulmonary artery pressure with St. Jude Medical’s CardioMEMS HF System can reduce hospitalizations without compromising kidney function in patients with renal failure.
The CardioMEMS HF System is a first-of-its-kind heart failure monitoring device that has proved to significantly reduce heart failure-related hospitalizations. A miniature wireless sensor that is threaded into the pulmonary artery is used to track the level of pressure borne by heart-failure patients.
The implantable device is designed to detect early signals of rising pressure and worsening heart failure. Patients can wirelessly transmit the readings to their doctor who can proactively manage medications and other treatment options to avoid a crisis that could result in hospitalization.
St. Jude Medical acquired privately held CardioMEMS, Inc. – the developer of the CardioMEMS HF System – in June this year, following the U.S. Food and Drug Administration’s (FDA) approval of the device in May.
The FDA approval of the CardioMEMS HF System was gained on the basis of earlier results from the CHAMPION trial, which found that monitoring the amount of pulmonary artery pressure via the implanted device lowered hospitalization rates by 28% at six months and 37% after an average of 15 months.
However, the agency requires the company to conduct a thorough post-approval study to ensure no unexpected risks or performance problems emerge when the device is used outside a clinical trial.
Last month, the Center for Medicare and Medicaid Services (CMS) approved a New Technology Add-on Payment (NTAP) for the CardioMEMS HF System. Under the NTAP program, which recognizes new technologies that provide substantial clinical benefits, Medicare patients will have timely access to CardioMEMS technology to proactively manage heart failure, improve patient outcomes and reduce hospital admissions.
Future Plans
With the closure of the CardioMEMS acquisition during the second quarter, St. Jude Medical expects accelerated growth in its cardiovascular segment. In its recent second-quarter earnings release, St. Jude Medical stated that it expects the monitoring system to generate $15–$20 million in sales in 2014.
St. Jude Medical now plans to commence the system’s launch in the U.S. and pioneer an entirely new market with this innovative technology. The company is also simultaneously beginning the process of establishing appropriate reimbursement for its CardioMEMS technology in key international markets.
During the remainder of this year, St. Jude Medical plans to initiate the FDA mandated post-approval clinical trial, establish key reference centers in the U.S., recognize any challenges that customers might face while incorporating the CardioMEMS technology into their existing heart failure program workflows, and refine the training and education process provided to both St. Jude Medical employees as well as customers.
Currently, St. Jude Medical carries a Zacks Rank #3 (Hold). Better-ranked stocks in the medical products industry include ICU Medical (ICUI), Abaxis, Inc. (ABAX) and Eagle Pharmaceuticals (EGRX). ICU Medical sports a Zacks Rank #1 (Strong Buy), while both Abaxis and Eagle Pharmaceuticals carry a Zacks Rank #2 (Buy).
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