St. Jude Medical Receives FDA Approval For 2 New Heart Devices, Addresing Previous Lead Abrasion And Safety Concerns

St. Jude Heart Monitoring Devices
The FDA has just approved the release of two new heart monitoring devices designed by St. Jude Medical Inc. St. Jude Medical Inc.

St. Jude Medical Inc. has just received the U.S. Food and Drug Administration's approval for two heart monitoring devices that provide adequate safety measures during electronic shock therapy treatments and deter lead abrasion.

The Ellipse implantable cardioverter defibrillator (ICD) and the Assura cardiac resynchronization therapy defibrillator (CRT-D) are the medical device company's newest developments in the U.S. According to The Motley Fool's report, the Eclipse ICD and Assura CRT-D were approved for European use just last year.

"The new safety features in these devices are an excellent example of innovation that improves patient safety," said Dr. Anne B. Curtis, chairman of the Department of Medicine with the University at Buffalo.

"The DynamicTx feature in the new Ellipse and SJM Assura devices provides an additional safeguard to ensure the patient receives live-saving therapy delivery even if an electrical short were to occur. In addition, St. Jude Medical is the first company to help address the problem of lead-to-can abrasion by providing increased insulation on the ICD device itself, rather than the lead."

The Eclipse ICD is advertised as a smaller option in size compared to other heart monitoring device while still providing the same level of energy, longevity, safety, and reliability. This device is specifically designed to rapidly identify irregular heartbeats before they turn into a sudden cardiac arrest.

According the Centers for Disease Control and Prevention's data, 92 percent of the 300,000 out-of-hospital cardiac arrest cases recognized each year end in death.

The Assura CRT-D is designed to resynchronize heartbeat of a patient who has suffered from heart failure in the past. It also provides a backup treatment for cardiac arrest, which is highly prevalent in those who have experienced heart failure, an incurable condition that currently affects five million people in the United States, the American Heart Association reports.

"St. Jude Medical strives to deliver the highest levels of patient safety. The new Ellipse ICD and SJM Assura family of devices support those efforts by providing added features that ensure effective therapy delivery," said Eric S. Fain, M.D., president of the St. Jude Medical Implantable Electronic Systems Division.

"We are pleased that the FDA approved these devices, allowing us to bring important safety and system reliability enhancements to patients."

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