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Last $73.63 USD
Change Today +0.56 / 0.77%
Volume 1.4M
STJ On Other Exchanges
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As of 6:40 PM 07/1/15 All times are local (Market data is delayed by at least 15 minutes).

st jude medical inc (STJ) Key Developments

St. Jude Medical Inc. Presents at Medical Device Conference 2015, Jun-26-2015 01:10 PM

St. Jude Medical Inc. Presents at Medical Device Conference 2015, Jun-26-2015 01:10 PM. Venue: Palace Hotel, 2 New Montgomery Street, San Francisco, California, United States. Speakers: Eric S. Fain, Group President.

St. Jude Medical Inc. Announces Encouraging Results from Coronary Artery Disease Studies

St. Jude Medical Inc. has announced results from two clinical studies which support the use of the company's fractional flow reserve, or FFR, technology to optimize percutaneous coronary intervention, or PCI, procedures used to restore blood flow to the heart in patients with coronary artery disease. The studies -15-year follow-up to the DEFER study and primary results from the CONTRAST study were presented. Combined, the studies contribute to the growing body of evidence supporting FFR as a valuable and important decision-making tool for physicians. St. Jude Medical's PressureWire FFR technology supports better treatment decisions for patients by providing a more detailed, physiologic analysis of blood flow blockages in the heart. Specifically, FFR can help accurately identify which coronary lesions or blockages are responsible for obstructing the flow of blood to a patient's heart muscle. This insight allows physicians to determine which lesions warrant stenting, resulting in improved patient outcomes and reduced health care costs. In a 15-year follow up study, new data from the DEFER study confirms original and five-year findings. Researchers leading the DEFER study found the positive benefits of decisions based on St. Jude Medical PressureWire FFR guidance were sustained after 15 years. The study also found the risk for a myocardial infarction was 6.5 times lower in patients where treatment was guided by FFR compared to patients in the non-FFR guided group, while finding no negative effect of leaving non-significant lesions untreated. The DEFER study's 15 year data is an important advancement of FFR, because it confirms sustained benefits of FFR guidance over time. After 15 years, DEFER researchers found stenting a non-ischemic stenosis, or narrowing of the blood vessel restricting blood flow to the heart, had no benefit compared to patients treated by standard medical therapy. In addition to a reduction in heart attacks, patients where revascularization was deferred had very low rates of complications compared to patients in which lesions were treated without proof of ischemia. In the CONTRAST study, researchers assessed FFR differently, and compared the gold standard in vascular physiologic assessment, FFR using adenosine, to resting indices (Pd/Pa and iFR) and a new approach to adenosine-free FFR; FFR using contrast medium. Contrast FFR (cFFR), also known as contrast Pd/Pa, is a new diagnostic approach where the hyperemic effect (an increase in blood flow) is induced by contrast medium in place of adenosine. The study found that cFFR provides superior accuracy compared to resting indices such as iFR or resting Pd/Pa. To date, simplifying physiologic assessment using resting indices has resulted in a reduction in accuracy, which has limited adoption. The CONTRAST study found both Pd/Pa and iFR to offer similar rates of accuracy. In addition, the study's researchers concluded cFFR did not add extra cost or procedure time and may be a viable option for situations where the use of adenosine is undesired or contra indicated.

St. Jude Medical Inc. Receives CE Mark Approval and the European Launch of the St. Jude MedicalInvisible Trial System

St. Jude Medical Inc. announced CE Mark approval and the European launch of the St. Jude MedicalInvisible Trial System, an app-based and wireless neuromodulation programming system leveraging Apple™ iPod touch™ and iPad mini™ technology. Like other Apple products, the new St. Jude Medical system relies on Bluetooth communication, providing a secure, safe, and wireless experience when patients trial spinal cord stimulation for the treatment of chronic pain prior to permanent implantation. One of the key system features of the Invisible Trial System is the use of an external pulse generator (EPG) as the system’s power source. The EPG is small, and uses Bluetooth communication to communicate between the patient’s iPod touch controller and the stimulation system. As a result, the system can now be worn under a patient’s clothing, often rendering the entire system “invisible” and providing a more comfortable trial experience. The goal is for patients to focus more on potential pain relief and therapeutic impact during their trial and less on the trial system itself. The iPod touch controller offers patients a simple, familiar platform to adjust their therapy. An iPad mini tablet is used by the patient’s physician to set the programming parameters. The programmer also displays trial usage data from the EPG and allows the physician to print or email the data in PDF format. Bluetooth technology safely and securely communicates wirelessly between the EPG and patient and physician devices, eliminating the programming trial cable and thus increasing the patient’s comfort. The new trial system has the capability to deliver both traditional and Burst stimulation modes. Burst stimulation has been demonstrated to minimize paresthesia in most patients. Paresthesia is a sensation which can often fluctuate with posture and body position changes and negatively impact the trial experience. Being able to utilize the Burst stimulation mode in a trial setting expands the range of available stimulation modes for chronic pain sufferers in the trial phase and in addition offers the potential to trial Burst stimulation for patients who did not respond to traditional tonic stimulation previously.

St. Jude Medical Announces Encouraging Data from new analysis of the CHAMPION trial with CardioMEMS HF system for the management of Class III heart failure patients

St. Jude Medical Inc. has announced encouraging data from a new analysis of the CHAMPION trial with CardioMEMS HF system for the management of Class III heart failure patients. The retrospective analysis showed that heart failure (HF) management using pulmonary artery (PA) pressure monitoring improved outcomes in patients already receiving optimal treatment including both medical management with Guideline Directed Medical Therapy (GDMT) and device therapy with an implantable rhythm device, such as an ICD or CRT device. A new economic analysis of data from the CHAMPION trial showed an Incremental Cost-Effectiveness Ratio (ICER) based on all-cause comprehensive management of heart failure patients of $30,167 per quality adjusted life year (QALY) gained when the patients were managed by PA pressure monitoring. The ICER is a statistic used to summarize the cost-effectiveness of a health care intervention. It is defined by the difference in cost between two possible therapeutic interventions, divided by the difference in their effect on quality of life and survival.

St. Jude Medical Inc. Announces New Results from Two Clinical Studies Adds Evidence Supporting Use of St. Jude Medical Fractional Flow Reserve Technology

St. Jude Medical Inc. announced that new results from two clinical studies further supporting the use of St. Jude Medical fractional flow reserve (FFR) technology to optimize percutaneous coronary intervention (PCI) procedures used to restore blood flow to the heart. The studies – a 15-year follow-up to the DEFER study and primary results from the CONTRAST study – were presented earlier during hotline sessions at EuroPCR 2015. Combined, the studies contribute to the growing body of evidence supporting FFR as a valuable and important decision-making tool for physicians. St. Jude Medical’s PressureWire FFR technology supports better treatment decisions for patients by providing a more detailed, physiologic analysis of blood flow blockages in the heart. Specifically, FFR can help accurately identify which coronary lesions or blockages are responsible for obstructing the flow of blood to a patient’s heart muscle. This insight allows physicians to determine which lesions warrant stenting, resulting in improved patient outcomes and reduced health care costs. In a 15-year follow up study, new data from the DEFER study confirms original and five-year findings. Researchers leading the DEFER study found the positive benefits of decisions based on St. Jude Medical PressureWire FFR guidance were sustained after 15 years. The study also found the risk for a myocardial infarction was 6.5 times lower in patients where treatment was guided by FFR compared to patients in the non-FFR guided group, while finding no negative effect of leaving non-significant lesions untreated. The DEFER study’s 15 year data is an important advancement of FFR, because it confirms sustained benefits of FFR guidance over time. After 15 years, DEFER researchers found stenting a non-ischemic stenosis, or narrowing of the blood vessel restricting blood flow to the heart, had no benefit compared to patients treated by standard medical therapy. In addition to a reduction in heart attacks, patients where revascularization was deferred had very low rates of complications compared to patients in which lesions were treated without proof of ischemia. In the CONTRAST study, researchers assessed FFR differently, and compared the gold standard in vascular physiologic assessment, FFR using adenosine, to resting indices (Pd/Pa and iFR) and a new approach to adenosine-free FFR; FFR using contrast medium. Contrast FFR (cFFR), also known as contrast Pd/Pa, is a new diagnostic approach where the hyperemic effect (an increase in blood flow) is induced by contrast medium in place of adenosine. The study found that cFFR provides superior accuracy compared to resting indices such as iFR or resting Pd/Pa. To date, simplifying physiologic assessment using resting indices has resulted in a reduction in accuracy, which has limited adoption. The CONTRAST study found both Pd/Pa and iFR to offer similar rates of accuracy. In addition, the study’s researchers concluded cFFR did not add extra cost or procedure time and may be a viable option for situations where the use of adenosine is undesired or contra indicated.

 

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