St. Jude Medical, Inc. - Unify CRT-D
by St. Jude Medical, Inc.

St. Jude Medical, Inc. Unify CRT-D Forums

1 Reply

I'm a dental hygienist and want to know if a cavitron device can be used on pt's with this device.

 

Adriana

RE: St. Jude Medical, Inc. - Unify CRT-D
Added  Feb 9 2015
0 Replies

I cannot find any reference a model cd3365 on the internet. I was given one last week and would like to have more info on this unit.

RE: St. Jude Medical, Inc. - Unify CRT-D
Added  May 8 2014
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I was talking with a gentleman planning to move into one of our apartment buildings.  He has a CD3231-40Q unit and indicated that it is monitored 24/7 and needs a phone line, although he only has one phone line and can still use it for calls while the monitoring is going on.  Do you have some literature on how this transmission works so that I can provide the correct communications for him when it is time to move?   Many thanks.

RE: St. Jude Medical, Inc. - Unify CRT-D
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What is the battery capacity in Amp Hours of the SJM Unify CRT-D? I am unable to find any clinician or user manuals.

RE: St. Jude Medical, Inc. - Unify CRT-D
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How susceptible or possibly interfering is the RF of a St. Jude ICD CD3231-40 implanted device near Bluetooth devices when remote device transmit and receive signals are in process? Is this a limiting consideration for heart patients with these models of devices? Recommendations for connecting and working with Bluetooth devices are that no other radio frequency devices be nearby or within the range of Bluetooth devices in question. Basic short distance for PC to Bluetooth devices seems to begin at 33 feet and goes up from there to 3,600 or more feet for more powerful Bluetooth signals.

RE: St. Jude Medical, Inc. - Unify CRT-D
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Unify Quadra offers the benefits of quadripolar pacing in a device with the industry's smallest footprint

ST. PAUL, Minn., Sep 20, 2011 (BUSINESS WIRE) --

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the European launch of the Unify Quadra(TM) cardiac resynchronization therapy defibrillator (CRT-D). The Unify Quadra CRT-D works with the company's Quartet(TM) left ventricular pacing lead. The combined system offers physicians the ability to effectively and efficiently manage the changing pacing needs of patients with heart failure with a downsized quadripolar pacing system. In Europe, heart failure affects more than 14 million people, and is projected to affect about 30 million by 2020.

St. Jude Medical introduced quadripolar technology last year in Europe with the Promote Quadra(TM) CRT-D, and is the only company to offer quadripolar technology. The system integrates multiple pacing configurations and features that enable physicians to optimize the system at implant and throughout the life of the patient, as well as better manage common pacing complications without exposing the patient to additional surgeries to reposition the lead.

The Unify Quadra is the next generation of the technology, providing all the benefits of quadripolar technology in a device with the industry's smallest footprint. The device's narrower shape allows physicians to implant the system using a shorter incision, with less time spent closing the incision, and a smaller scar for the patient.

The Unify Quadra uses the new International Standards Organization (ISO) DF4 and IS4 connector specifications to further streamline the procedure. The DF4 connector reduces the number of connections between the defibrillation lead and the device, which can improve patient comfort by reducing the bulk of wires in the patient's chest. The IS4 connector enables four electrodes to be used on the Quartet left ventricular pacing lead while connecting to a single standard connector on the Unify Quadra device.

The Quartet left ventricular pacing lead - used as part of the Unify Quadra system - features four electrodes, instead of the usual two. Multiple pacing configurations allow the physician more options, including pacing closer to the base of the left ventricle, which recent studies associate with better patient outcomes and which may be less possible with traditional leads that only have two electrodes. The quadripolar pacing electrodes also provide physicians additional benefits, such as pacing around scar tissue in the heart and avoiding the most common pacing complications.

Commenting on the technology, Dr. Amir Zaidi, consultant cardiologist at the Central Manchester University Hospitals NHS Foundation Trust, said, "Diaphragmatic stimulation is the most common implant-related problem that prevents my patients from receiving effective cardiac resynchronization therapy. Unify Quadra is my "go to" technology in these cases and I believe its benefits can make it the standard of care for cardiac resynchronization. With quadripolar technology, I can deliver effective treatment to patients who would otherwise be denied gold-standard therapy for heart failure using conventional CRT devices."

Because the physician can non-invasively adjust pacing locations or configurations, the technology has the potential to reduce patients' risk of needing multiple surgeries. This is important because some complications, such as phrenic nerve or diaphragmatic stimulation are body-position sensitive and may not be evident while patients are lying on their back during the implantation procedure. More than thirty publications provide clinical evidence supporting the benefits of the quadripolar technology in managing common pacing complications, enabling better clinical efficiency, and providing a greater opportunity for efficacy.

"This new system is designed to manage the dynamic challenges of heart failure," said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. "Based on the clinical evidence, positive experiences and publications to date, this innovative CRT system has the potential to redefine the standard of care in resynchronization therapy for heart failure patients around the world."

In heart failure patients, the heart often beats out of sync. Cardiac resynchronization therapy resynchronizes the beating of the heart by pacing both lower chambers (ventricles) rather than just one (the right ventricle). Studies have shown that CRT can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood. Currently, heart failure results in more than 3.6 million hospitalizations per year in Europe, and related costs represent approximately 2 percent of overall health care expenditures.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company's Annual Report on Form 10-K for the fiscal year ended January 1, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended July 2, 2011. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

SOURCE: St. Jude Medical, Inc.

RE: St. Jude Medical, Inc. - Unify CRT-D
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22 Dec 2010 St. Michael's Hospital has just become the first in Ontario to implant a small but powerful new defibrillator into a patient's chest. The defibrillator - about the size of a Zippo lighter - is the smallest available in terms of surface area and can deliver the highest level of energy, 40 joules. The narrow shape of the device allowed Dr. Iqwal Mangat to make a smaller incision in the patient's chest, which should mean a faster recovery and smaller scar. The "minimally invasive" procedure is performed on an outpatient basis, with most patients going home the same day. The small size also means less patient discomfort and less obvious signs of the device under the patient's skin. The high-energy capability of this device is especially important for patients who have an enlarged weak heart, advanced heart failure or have previously required a high amount of energy to shock their heart back to a normal rhythm.. This device is also coupled with an additional lead on the left side of the heart that allows the heart to "resynchronize," potentially allowing patients to feel more energy and less short of breath. "The more energy there is in a device to shock a patient, the more likely it is their life will be saved by that device," said Dr. Mangat, director of the hospital's arrhythmia services. "Most people don't need a lot of energy, but sometimes they do." Notes: The new Unify CRT-D defibrillator is made by St. Jude Medical, Inc., based in St. Paul, MN. St. Michael's implants about 290 defibrillators and 230 pacemakers a year. What is the difference between a pacemaker and an implanted defibrillator? A pacemaker is about one-quarter the size of a defibrillator. It monitors your heart rhythm - which slows with age and certain medications - and sends electrical pulses to your heart if it is beating too slow or you miss a heartbeat. A defibrillator is a small, battery-powered device that treats a dangerous fast heart rhythm by delivering a jolt of electricity to the heart. They are typically implanted in patients who have or are at risk for developing ventricular tachycardia or ventricular fibrillation, two types of very fast and life-threatening heart rhythms that originate from the ventricles, the lower chambers of the heart. Source: Leslie Shepherd St. Michael's Hospital [url=http://www.medicalnewstoday.com/articles/212255.php] View Original Article[/url]

RE: St. Jude Medical, Inc. - Unify CRT-D
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New products help ensure effective therapy delivery, have longer battery life and can be implanted through a smaller incision due to reduced size.

ST. PAUL, Minn. – May 12, 2010 – St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval and first U.S. implants of its Unify™ cardiac resynchronization therapy defibrillator (CRT-D) and Fortify™ implantable cardioverter
defibrillator (ICD). The new devices feature advanced battery technology and circuitry that allow for the smallest device footprint in the industry and rapid charge times, without any compromise in device longevity or power.

The Unify CRT-D and Fortify ICD have 45J of stored energy and can deliver 40J, the highest energy of any ICD available today. This high energy capacity gives these devices the ability to provide a greater safety margin, which could increase the chances that therapy will be successful for patients who may need more energy to correct their heart rhythm. Increasing the chance that therapy will be successful
also decreases the chance that additional electrodes, such as a subcutaneous lead, will be required to defibrillate the heart. The energy capability of a device is particularly important for patients who have an enlarged heart, low ejection-fraction, advanced heart failure or previously demonstrated a high defibrillation threshold (the amount of energy required to shock the heart back to a normal rhythm).
The devices’ narrow shape, along with their small footprint, allows physicians to implant them using a smaller incision, leading to less time spent closing the incision and a reduced scar for the patient. The company’s SJ4 lead connector system further streamlines the procedure by reducing the number of set
screws and connections between the defibrillation lead and the device, which can improve patient comfort by reducing the bulk of wires in the patient’s chest.

“These devices offer a number of new features designed to address many of the clinical issues facing our patients while still delivering the reliability, power and longevity I expect from a St. Jude Medical device,” said Dr. Robert P. Styperek, F.A.C.C., Harbin Clinic Physician, Director of Electrophysiology, at Redmond Regional Medical Center in Rome, Ga. “The devices’ smaller shape, combined with the SJ4 connector system, streamlines the implant procedure and can make the device more comfortable for patients. To become accustomed to this outstanding improvement, all I need to do now is shorten the length of my incision.”

Both devices also have features designed to reduce inappropriate or unnecessary defibrillation therapy,while ensuring effective therapy occurs when the patient needs it. The features include advanced sensing technology and more anti-tachycardia pacing options, which can convert many fast ventricular arrhythmias painlessly and avoid the need for high voltage shocks.

“The release of the Unify CRT-D and Fortify ICD families is a strong demonstration of our commitment to providing physicians with technology that puts more control in their hands,” said Eric S. Fain, M.D.,president of the St. Jude Medical Cardiac Rhythm Management Division. “Our goal with these product
lines is to provide physicians with solutions that address their most significant clinical challenges,including patient safety and inappropriate therapy, and to do so while reducing the size of the device.”

An ICD is an advanced implantable device that treats potentially lethal, abnormally fast heart rhythms (ventricular tachycardias or ventricular fibrillation), which often lead to sudden cardiac death (SCD).Approximately 325,000 people per year in the U.S. die suddenly of SCD.

A CRT-D device resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure patients, and provides back up treatment for SCD, which is a risk factor associated with certain types of heart failure. Studies have shown that CRT (cardiac resynchronization
therapy) can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood. About five million Americans suffer from heart failure, with 550,000 new cases diagnosed every year, according to the
American Heart Association.

The Unify CRT-D and Fortify ICD previously received European CE Mark approval and were recently fully-launched in Europe.

CONTACTS:
Angie Craig
Investor Relations
Tel 651 756 2191
acraig@sjm.com

Amy Jo Meyer
Media Relations
Tel 651 756 3029
ameyer@sjm.com

Article Source-St.Jude Medical

RE: St. Jude Medical, Inc. - Unify CRT-D

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