St. Jude Medical Announces FDA Approval And U.S. Market Launch Of Merlin Patient Care System
St. Paul, MN -St. Jude Medical, Inc. announced U.S. Food and Drug Administration (FDA) approval and market launch of its Merlin Patient Care System, a universal programmer for implantable cardioverter defibrillators (ICDs) and pacemakers. The system is designed to help physicians more efficiently conduct tests, analyze therapeutic and diagnostic data, and program implanted devices for optimal patient care.
The system, which supports current and previous generation devices, represents a significant market launch for St. Jude Medical and is one of more than 20 new cardiac rhythm management products expected to be introduced this year. St. Jude Medical will launch the new system over the coming weeks. Further FDA approvals for additional Merlin graphical user interface upgrades for ICDs are expected later this year.
"We're seeing a growing number of patients with implantable devices that need follow-up testing, and the Merlin Patient Care System allows us to conduct more follow-ups in less time with a high degree of patient satisfaction," said Carlos Rizo-Patron, M.D., of Cardiac Arrhythmia Services in Lubbock, Texas. "It is a fast and easy to use follow-up system, and we can rely on it to assess a full range of pacemaker and ICD patients."
The Merlin Patient Care System is a powerful, portable computer that helps physicians retrieve and analyze patient information during routine follow-up visits. Physicians can quickly and easily make changes to device therapy through an LCD touch-screen. The system's intuitive workflow can increase productivity for physicians and clinic staff. With the Merlin System, patients will receive the same high-standard of care, but follow-up visits will take significantly less time.
Patients with pacemakers or ICDs require regular follow-up exams to make sure devices are delivering appropriate therapy and to review changes in patient health. If a patient's condition has changed, clinicians can program new instructions into the device to help protect the patient from abnormal heart rhythms.
"The best way to create a patient follow-up system is to ask the clinicians who conduct the testing every day what they want most, and that's exactly what we did for the Merlin Patient Care System," said Michael J. Coyle, president of St. Jude Medical's Cardiac Rhythm Management Division. "We invested countless hours watching how clinicians work, and then challenged some of our best people to streamline the process and make it easier to navigate."
The Merlin Patient Care System includes several advantages for physicians and patients:
- A new user interface that makes the entire system faster to learn and use. This interface, which is currently available for pacemakers and is expected to be available for ICDs later this year, mimics the natural workflow of a clinic to make it easier for clinicians to operate.
- Enhanced presentation of diagnostics, which consolidate and display patient information so clinicians can make faster decisions.
- State-of-the-art hardware, including a powerful Intel Pentium M processor, an expanded disk and flexible options for future upgrades. The hardware increases speed and consumes less energy, allowing the system to weigh less, thereby making it easier for physicians and nurses to carry and store.
- The industry's first session summary screen, which shows a summary of tests performed during a pacemaker patient's follow-up exam, and shows a comparison between presenting settings and currently programmed settings. This feature also is expected to be available for ICD patients later this year.
SOURCE: St. Jude Medical