st jude medical inc (STJ) Key Developments
St. Jude Medical, Inc. Announces FDA Approval of The New Proclaim™ Elite Spinal Cord Stimulation System
Nov 19 15
St. Jude Medical Inc. announced FDA approval of the new Proclaim™ Elite Spinal Cord Stimulation System, the first and only upgradeable and recharge-free spinal cord stimulation (SCS) system available to people in the U.S. suffering from chronic pain. The approval also includes conditional magnetic resonance (MR) labeling for the Proclaim Elite SCS system, which will allow patients to safely undergo head and extremity MRI scans. The current approval also includes the company’s new, innovative clinician programmer, which allows clinicians to program and adjust their patient’s spinal cord stimulation therapy with an Apple™ iPad mini™ mobile digital device. In addition, patients will be able to evaluate spinal cord stimulation with the St. Jude Medical™ Invisible Trial System, a discreet, app-based and wireless neuromodulation programming system leveraging Apple™ iPad touch™ mobile digital devices. According to the Institute of Medicine, chronic pain affects more than 100 million Americans, an incidence rate which outpaces heart disease, cancer and diabetes combined. Past research has suggested that the condition can cost the American population an estimated 515 million workdays annually and generates upwards of 40 million visits to physicians each year. St. Jude Medical designed many elements of the Proclaim system based on physician and patient feedback to ensure patients could benefit from all aspects of the product. In particular, the non-rechargeable system improves patient convenience by removing the burden of regularly recharging the SCS system. The system’s upgradable platform allows patients to access future SCS technology upgrades, such as new stimulation waveforms and software updates, without surgical device replacement. Historically, most patients would need additional surgery to receive product upgrades as they are approved. With its latest round of SCS product offerings, St. Jude Medical aims to further enhance ease-of-use and familiarity for patients by leveraging Bluetooth wireless technology and Apple™ mobile digital devices for the Proclaim Elite SCS system’s patient controller and clinician programmer. This approach will allow patients to interact with their device more easily, which can ensure effective management of their chronic pain treatment with minimal disruption to their daily life.
St. Jude Medical Inc. Reports Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended October 03, 2015; Provides Earnings Guidance for the Fourth Quarter and Full Year of 2015
Oct 21 15
St. Jude Medical Inc. reported unaudited consolidated earnings results for the third quarter and nine months ended October 03, 2015. For the quarter, the company reported net sales of $1,339 million compared to $1,372 million a year ago. Operating profit was $294 million compared to $270 million a year ago. Earnings before non-controlling interest and income taxes were $261 million compared to $250 million a year ago. Net earnings attributable to the company were $215 million compared to $238 million a year ago. Diluted net earnings per share attributable to the company were $0.75 compared to $0.82 a year ago. Adjusted diluted net earnings per share attributable to the company were $0.97 compared to $1.02 a year ago. Adjusted Earnings before non-controlling interest and income taxes were $330 million compared to $357 million a year ago. Adjusted net earnings attributable to the company were $277 million compared to $296 million a year ago.
For the nine months, the company reported net sales of $4,094 million compared to $4,183 million a year ago. Operating profit was $933 million compared to $871 million a year ago. Earnings before non-controlling interest and income taxes were $863 million compared to $810 million a year ago. Net earnings attributable to the company were $767 million compared to $757 million a year ago. Diluted net earnings per share attributable to the company were $2.68 compared to $2.62 a year ago. Adjusted diluted net earnings per share attributable to the company were $2.92 compared to $3.09 a year ago. Adjusted Earnings before non-controlling interest and income taxes were $989 million compared to $1,077 million a year ago. Adjusted net earnings attributable to the company were $836 million compared to $895 million a year ago.
The company provided earnings guidance for the fourth quarter and full year of 2015. For the quarter, the company expects adjusted net earnings to be in the range of $1.00 to $1.02 per share. Diluted net earnings per share attributable to the company expected to be in the range of $0.35 to $0.41. Sales expected to be in the range of $1,455 million to $1,480 million.
For the full year, the company expects adjusted net earnings to be in the range of $3.93 to $3.95 per share. Diluted net earnings per share attributable to the company expected to be in the range of $3.04 to $3.10. Sales expected to be in the range of $5,549 million to $5,574 million. For the full year 2015, the company expects the effective tax rate to be approximately 16.5% to 17.0%.
St. Jude Medical Inc. Presents at Credit Suisse 24th Annual Healthcare Conference, Nov-10-2015 10:30 AM
Oct 19 15
St. Jude Medical Inc. Presents at Credit Suisse 24th Annual Healthcare Conference, Nov-10-2015 10:30 AM. Venue: The Phoenician Hotel, Scottsdale, Arizona, United States. Speakers: Eric S. Fain, Group President, Michael T. Rousseau, Chief Operating Officer.
St. Jude Medical, Inc. Announces Results from the Shield I, Coronary Interventions in High-Risk Patients Using Novel Percutaneous Left Ventricular Support Device Study
Oct 14 15
St. Jude Medical Inc. announced results from the SHIELD I, Coronary InterventionS in HIgh-Risk PatiEnts Using a Novel Percutaneous Left Ventricular Support Device study that confirm the benefits of the HeartMate PHP™ (Percutaneous Heart Pump) cardiac assist device for patients undergoing high-risk percutaneous coronary intervention (PCI), a procedure to restore blood flow to the heart. The study demonstrated that consistent, stable hemodynamics were maintained during revascularization when assisted by the HeartMate PHP cardiac assist device. SHIELD I is a prospective, nonrandomized, open-label, multicenter trial that evaluated the use of the HeartMate PHP cardiac assist device in patients who required hemodynamic (circulatory) support during complex PCI procedures. The study results from the first 46 patients were presented at the 27th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation in San Francisco, Calif. During a PCI procedure, the heart experiences interruptions to blood flow. The minimally invasive HeartMate PHP cardiac assist device is placed via catheter to temporarily assist circulation by continuously pumping blood during PCI, providing physicians more options for high-risk patients. Unlike traditional catheter-based support devices, the HeartMate PHP cardiac assist device can generate an average blood flow of four to five liters per minute, which is the normal amount of blood pumped out by the left ventricle. Data from SHIELD I show the trial met both endpoints for primary performance (freedom from hemodynamic compromise during PCI) and safety (a composite of major adverse events). In addition, data from SHIELD I showed: Low complication rates. Researchers leading SHIELD I did not observe any cases of device- related cardiac death or myocardial infarction, no intraprocedural hypotension, and the overall incidence of complications related to the HeartMate PHP device was low; Ease of use. The research team highlighted the consistent and efficient implantation process offered by the HeartMate PHP device.
St. Jude Medical, Inc. Announces CE Mark Approval for the HeartMate 3 Left Ventricular Assist System
Oct 12 15
St. Jude Medical Inc. announced that the company has received CE Mark approval for the HeartMate 3 Left Ventricular Assist System (LVAS), a cardiac support option for advanced heart failure patients who are awaiting transplantation, are not candidates for heart transplantation, or are in myocardial recovery. The HeartMate 3 system is the first commercially approved centrifugal-flow left ventricular assist device (LVAD) utilizing Full MagLev (fully magnetically-levitated) technology, which allows the device’s rotor to be 'suspended' by magnetic forces. This design aims to reduce trauma to blood passing through the pump and improve outcomes for patients. The device is implanted above the diaphragm, immediately next to the native heart, and is attached to the aorta leaving natural circulation in place while providing all of the energy necessary to propel blood throughout the body. CE Mark approval for the HeartMate 3 system was based on data from the HeartMate 3 CE Mark clinical trial, which met its primary endpoint and demonstrated a 92% six month survival rate; the best six month survival rate to date to be documented in an LVAD CE Mark clinical study. Unlike artificial hearts, LVADs don’t replace the heart. Instead, the small implantable devices supplement the pumping function of the heart in patients whose hearts are too weak to pump blood adequately on their own. LVADs can benefit patients either awaiting transplant, known as bridge to transplant therapy, or can be used as a 'destination therapy' for heart failure patients who need years of cardiac support but who are not candidates for transplantation. The design of the HeartMate 3 LVAD includes large, consistent blood flow gaps over a wide range of device operation levels, designed to reduce blood trauma. The artificial pulse technology is designed to further reduce adverse patient events including combatting the formation of thrombus in the device. The HeartMate 3 CE Mark clinical trial, which concluded in November 2014, enrolled 50 patients at 10 hospitals in six countries outside the U.S. Enrollment included both bridge-to-transplant and destination therapy patients in New York Hospital Association Class IIIb or IV heart failure. The study met its primary endpoint by demonstrating a six month survival rate of 92% with the HeartMate 3 LVAS, as well as overall adverse event rates that were either lower or consistent with expectations for severely ill and complex patients requiring LVAD support. In the U.S., the HeartMate 3 system is in an ongoing IDE trial. The MOMENTUM 3 IDE trial, the large of its kind, remains ongoing and will enroll more than 1,000 patients.