|St. Jude Announces First US Patient Implant Cardiac Pacemaker; Xerox Expands Healthcare Research in India, New York|
|By Mary Davila|
|Thursday, 06 February 2014 20:50|
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the first U.S. implant in the company’s LEADLESS II pivotal trial designed to evaluate the Nanostim™ leadless pacemaker for U.S. Food and Drug Administration (FDA) approval. The world’s first retrievable, non-surgical pacemaker was implanted at The Mount Sinai Hospital in New York City by Dr. Vivek Reddy.
The Nanostim leadless pacemaker is designed to be placed directly in the heart without the visible surgical pocket, scar and insulated wires (called leads) required for conventional pacemakers. Implanted via the femoral vein with a steerable catheter, the device offers physicians the same pacing therapy through a less-invasive approach as compared to traditional pacemaker procedures that require more extensive surgery. The device is designed to be fully retrievable, so that it can be readily repositioned throughout the implant procedure and later retrieved if necessary.
“This clinical research trial will be testing the latest innovative, non-surgical pacemaker option for U.S. patients experiencing heart rhythm issues,” said the study’s co-investigator Dr. Vivek Reddy, Director of Electrophysiology Services at The Mount Sinai Hospital and Chairman of the Steering Committee of the study. “This new-age, tiny pacemaker may ultimately be safer for patients because it doesn’t have leads or have to be inserted under the skin of a patient’s chest, like a traditional cardiac pacemaker. I believe this pioneering, compact device, which is placed directly inside the heart, may be a true game-changing technology in cardiovascular medicine and may help revolutionize care for patients with arrhythmias. I look forward to the results of the LEADLESS II clinical trial.”
The Nanostim leadless pacemaker is less than 10 percent the size of a conventional pacemaker and is the least invasive pacing technology available today. The small size of the device and lack of a surgical pocket, coupled with the exclusion of a lead, improves patient comfort and may reduce complications, including device pocket-related infection and lead failure. The elimination of the visible lump and scar at a conventional pacemaker’s implant site, in addition to the removal of patient activity restrictions that are routinely put in place in an attempt to prevent dislodgement or damage to a conventional lead, will potentially improve the quality of life for patients with this technology by allowing most to continue living active, uninhibited lifestyles. The device is supported by the St. Jude Medical Merlin™ Programmer, which is also used to interrogate and program the company’s other pacemakers and implantable cardioverter defibrillators (ICDs).
“Since the introduction of the first implantable pacemaker in 1958, pacemaker technology has continued to evolve into smaller, more efficient devices,” said Dr. Mark D. Carlson, chief medical officer and vice president of global clinical affairs for St. Jude Medical. “Despite this evolution, pacing technology has, until now, required surgery in addition to leads that connect the pacemaker to the heart. The Nanostim leadless pacemaker is the first miniaturized device that removes the need for leads, thus offering less invasive and less complicated procedures for physicians and patients around the world. We believe the innovative nature of this technology will change the future landscape of cardiac rhythm management devices by revolutionizing the delivery methods and design of these life-saving technologies.”
Cardiac pacemakers are used to treat bradycardia, which is a heart rate that is too slow. These devices monitor the heart and provide electrical stimulation when the heart beats too slowly for each patient's specific physiological requirements. More than 4 million people worldwide have an implanted pacemaker or other cardiac rhythm management device, and an additional 700,000 patients receive the devices each year.
Chronic illnesses such as cardiovascular and respiratory diseases require continuous monitoring, which can be expensive and difficult, especially in remote areas and homes. The Xerox (NYSE:XRX) Innovation Group today announced a suite of healthcare research projects being conducted in India by Xerox Research Centre India (XRCI) and Xerox Research Center Webster (XRCW) in New York that use video cameras and data analytics to monitor a patient’s condition without wires, discomfort or risk of infection.
Scientists believe the contact-free approach will make it less intrusive to patients in India and across the globe for doctors to monitor the condition of their patients.
Working closely with the Manipal University Hospital in Manipal, India, Xerox researchers have been testing the feasibility of using video cameras to develop technologies that continuously monitor the condition of patients. Using patented software algorithms, Xerox scientists have been able to convert data collected by the cameras into vital signs. When a heart pumps, for example, freshly oxygenated blood makes the skin appear redder. A video camera documents these subtle changes that are imperceptible to the human eye, and a computer then calculates a heart rate. Because the cameras can scan skin from a distance, patients can – in theory – be free from wires, sensors and other devices that typically are used today.
“Our initial work at Manipal was in the neonatal unit, evaluating the algorithms to monitor infant vital signs with cameras, but that has quickly expanded into other areas,” said Lalit Mestha, research fellow at the Xerox research center in New York and project leader.
Using cameras to track a patient’s condition can improve comfort levels and decrease the risk of infection. Cameras can open up the possibility of diagnosing patients at their homes, clinics and in locations that may be far from a specialist.
Mestha’s team also is working with the University of Rochester Medical Center in New York on a project that uses cameras to detect occurrence of atrial fibrillation, a condition that can increase a person’s risk of stroke by a factor of five.
Research conducted in hospital rooms provides Xerox scientists with a first-hand view of the medical field through interaction with practitioners and patients.
“Our partnership with Manipal University Hospital is helping us move the technology closer to reality,” said Manish Gupta, Xerox vice president and director of XRCI. “This research can have great implications for the future of healthcare and telemedicine in India and across the globe.”
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