FDA Clears New Rapid, Large-Area, and Radiopaque Temperature Sensing Probe and System
CIRCA Scientific announced that its CIRCA S-CATH™ and CIRCA Temperature Monitoring System™ have received 510(k) clearance in the U.S. by the Food and Drug Administration (FDA).
The CIRCA S-CATH and the CIRCA Temperature Monitoring System address the problems associated with slow, single sensor, and small surface area standard esophageal temperature probes and monitors.
Standard esophageal temperature probes are constructed with a single thermistor or thermocouple embedded inside a 3-5mm wide probe tip. These standard probes are used during a variety of procedures but are slow to respond to temperature changes and difficult to see under x-ray guidance. For example, some temperature probes and monitors only display new temperatures 1 or 2 times every 2 seconds, and only cover a small 3-5mm wide area of the esophagus’s 10-20mm potential width.
CIRCA’s single-use S-CATH includes 12 temperature sensors that continuously sense for new temperatures. In addition, the S-CATH deploys in a two-plane modified “S” configuration to cover up to an 18mm+ wide area of the esophagus and improve esophageal visualization under x-ray.
The re-usable CIRCA Temperature Monitoring System is a compact touch screen monitor that displays the individual temperature of each sensor 20-times-per-second. The monitor also simultaneously displays the warmest sensor on the probe. Temperatures are displayed in numerical and graphical formats and the clinician can set audible/visual warnings and alarms.
“The CIRCA S-CATH and CIRCA Temperature Monitoring System can improve temperature sensing speed, surface area coverage, and fluoroscopic x-ray visibility in the esophagus,” explained Lee Geist, CIRCA Scientific’s Chief Executive Officer. “The CIRCA team did an excellent job creating a best-in-class temperature probe and monitoring system to improve the quality and quantity of temperature data for the clinician.”
CIRCA Scientific plans to launch the CIRCA S-CATH and the CIRCA Temperature Monitoring System in the United States in 2011. CIRCA Scientific was funded in 2010 based on intellectual property from Shawn Fojtik to innovate safe, accurate, and fast technologies for improved patient care. U.S. and foreign patents pending.
Costs, Mortality Skyrocket Following Infection in Cardiac Device Recipients
A new study finds that infections following cardiac device implantations or replacement result in extremely high costs, both financially and in terms of patient mortality, even months after affected patients return home. Infections associated with pacemakers and defibrillators led to 4.8 to 7.7-fold increases in admission mortality, 1.6 to 2.1-fold increases in long-term mortality, 2.5 to 4.0-fold increases in hospital length of stay, and 1.4 to 1.8-fold increases in cost compared to pacemaker and defibrillator implantations without infection. Surprisingly, more than one-third of the excess mortality occurred after hospital discharge. These findings, from a study of more than 200,000 Medicare beneficiaries receiving pacemaker and defibrillator implantations, with and without infection, were published, via ePub, by the Archives of Internal Medicine. The study risk-adjusted the outcomes for comorbidities and demographic characteristics.
“While Healthcare Reform has been a subject of intense debate lately, unfortunately, most attention and work has been centered on payment or insurance reform and little attention is being paid at reforming healthcare delivery and cost savings by disease prevention” stated M. Rizwan Sohail, MD, Assistant Professor of Medicine, Mayo Clinic College of Medicine, Rochester, MN, lead author of the new study. “However, in our current analysis, we have tried to bring the focus back to where it should be, and that is the enormous cost of complications and mortality associated with complex medical procedures. Prevention of these infectious complications can lead to major cost savings and improve survival in this group of patients.”
Key findings from the study included:
- The in-hospital mortality rate for pacemaker and defibrillator implantation admissions, with an infection, was 4.8- to 7.7-fold the rate for non-infected admissions, depending on the device type.
- The longer-term mortality rate (death during the admission quarter and following year) was 27-35%, about 1.6 to 2.1-fold the rate without infection, depending on the device type.
- The mean hospital length of stay (LOS) with infection was 2.5 to 4.0-fold the length of stay without infection.
- Mean total hospitalization cost for pacemaker and defibrillator patients with infection was 1.4-1.8 fold the cost for those without infection, depending on the type of device. The mean standardized incremental costs related to the treatment of the infection ranged from an average of $16,208 for pacemaker infections to $16,498 for certain types of defibrillators. The Medicare analysis revealed that the cost of managing the most extreme situations exceeded $1 million.
“Pacemaker and ICD therapies are invaluable tools in treating heart disease. The ‘2010 American Heart Association/Heart Rhythm Society Scientific Statement on Cardiac Implantable Electronic Device (CIED) Infections and their Management’ identified the need for more precise data on the clinical impact and economic burden of pacemaker and defibrillator infections,” commented Daniel Lerner, MD, Chief Medical Officer of TYRX Inc. “This large population study in a broad spectrum of patients provides important information on the significant impact that cardiac device infections have on mortality, morbidity, and health care costs. These findings further underscore the need for infection prevention as a key component of the larger health care imperative to reduce mortality, morbidity, and health care costs.”
The new study was conducted with financial support from TYRX, Inc.
ScImage Enhances Browser-Based ECG with Interactive Platform
Understanding the importance and immediacy of having ubiquitous access to raw ECG waveforms for clinical decision support, ScImage bolstered its already formidable browser-based ECG delivery utility in PicomWeb.
In keeping with their open-architecture philosophy for widespread, multi-platform accessibility, ScImage designed a streamlined new user interface based on advanced machine independent HTML5 codebase. This new ECG platform presents especially well in web tablets and smartphone profiles. Interactive navigation and manipulation are performed through gestures or clicks, depending on the platform.
This new design scheme will empower physicians to make urgent critical care decisions from remote locations with confidence.
ScImage’s PicomWeb platform extends the content of ScImage’s PicomEnterprise PACS to the ubiquitous web for complete access to multi-specialty imaging and reporting; for radiology, cardiology and other clinical specialties.
PicomECG is available as a standalone ECG management system, as part of an Enterprise-wide PACS, or as a Cloud-based service.
The company’s “Picom” trademark denotes Patient Information and Communication in Medicine, which expands on the image-centric DICOM concept of Digital Imaging and Communication in Medicine.
FDA Advisory Committee Recommends Approval of Oral Anticoagulant Rivaroxaban for the Prevention of Stroke and Systemic Embolism in Patients with Non-Valvular AF
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) announced that the U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee recommended approval of rivaroxaban, a novel, once-daily, oral anticoagulant, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF). The committee voted 9-2 in favor of rivaroxaban in patients with AF who are at risk of stroke and systemic embolism.
"We are pleased with the committee’s recommendation and look forward to working with the FDA to help make this important therapy available in the U.S.," said Peter M. DiBattiste, MD, Global Therapeutic Area Head, Cardiovascular and Metabolism, J&JPRD.
Data presented at the advisory committee meeting included results from the pivotal, global, double-blind Phase 3 ROCKET AF (Rivaroxaban Once-daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for the prevention of stroke and Embolism Trial in Atrial Fibrillation) clinical trial, which demonstrated that once-daily rivaroxaban had a 21% relative risk reduction in stroke and non-CNS systemic embolism while on-treatment compared to warfarin, with low and comparable bleeding rates.1
ROCKET AF compared oral, once-daily rivaroxaban with dose-adjusted warfarin in 14,264 patients with non-valvular AF who are at risk for stroke and non-CNS systemic embolism. The study was designed to first demonstrate that rivaroxaban was non-inferior to warfarin (the study’s primary efficacy endpoint). Once non-inferiority was established, data was assessed for superiority with an “on-treatment” population (i.e., patients on study drug and followed for events while on the drug for duration of the trial). The analysis for superiority was pre-specified. An additional confirmatory analysis was also performed in the intention to treat (ITT) population and including data to the end of the study. This group included all randomized patients followed for events, including periods both on and off treatment, until trial completion.
Recommendations from the advisory committee will be considered by the FDA in its review of the New Drug Application for rivaroxaban in this indication that was submitted by J&JPRD on January 5, 2011, but are not bound to directly follow them. If approved by the FDA, Janssen Pharmaceuticals, Inc. will commercialize rivaroxaban in the U.S.
XARELTO® (rivaroxaban tablets), was approved by the FDA on July 1, 2011 for the prevention (prophylaxis) of deep vein thrombosis (DVT) which may lead to a pulmonary embolism (PE) in people undergoing knee or hip replacement surgery. It works by blocking the blood clotting Factor Xa and thereby reduces the tendency of the blood to form clots.
Additionally, XARELTO® is being investigated for the prevention and treatment of a broad range of disorders in which blood clotting plays a major role. The extensive program of clinical trials evaluating rivaroxaban makes the compound the most studied oral, Factor Xa inhibitor in the world today. By the time of its completion, more than 65,000 patients will have participated in the rivaroxaban clinical development program. Rivaroxaban is being developed jointly by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Bayer HealthCare.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is a wholly-owned subsidiary of Johnson & Johnson, the world's most broadly based producer of health care products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Europe, the United States and Asia. J&JPRD is actively involved in drug discovery and development within a variety of therapeutic areas, including Cardiovascular and Metabolism, Central Nervous System, Immunology, Oncology and Virology, to address unmet medical needs worldwide.
Janssen Pharmaceuticals, Inc.
As a member of the Janssen Pharmaceutical Companies of Johnson & Johnson, Janssen Pharmaceuticals, Inc., is dedicated to addressing and solving some of the most important unmet medical needs in pain management, infectious diseases and cardiovascular and metabolic diseases.
Important Safety Information
What is XARELTO®?
XARELTO®(rivaroxaban tablets) is a prescription medicine used to help prevent blood clots from forming in patients after hip or knee replacement surgery.
What is the Most Important Information I Should Know About XARELTO®?
- You should take XARELTO® exactly as directed by your doctor
- Do not skip a dose or stop taking XARELTO® unless you are advised to do so by your doctor. Stopping may increase your risk of a blood clot
- If a dose is missed, take XARELTO as soon as possible and continue on the following day, taking XARELTO® as directed by your doctor. Do not take two doses at the same time
- XARELTO® can cause bleeding, which can sometimes be serious, even life-threatening. You may find you bruise or bleed more easily while you take it. It might take longer than usual to stop bleeding
Alert your doctor right away if you develop any:
- Tingling, numbness or muscle weakness, especially in your legs. This is particularly important if you had a procedure called spinal or epidural puncture as part of your anesthesia for your hip or knee replacement surgery.
- Unusual bleeding or bruising (bruises that develop without an injury or grow in size)
- New bleeding (for example, nose bleeds, bleeding gums, red urine, bright red blood in your stool, coughing up or vomiting blood)
- Bleeding that is heavier than usual (for example, from cuts or menstruation)
- Dizziness, weakness, or tiredness, all of which could indicate a loss of blood
- Pain, swelling, or new fluid leakage in or around the surgical incision
Who Should Not Take XARELTO®?
Tell your doctor if you have:
- Unusual bleeding
- Ever had an allergic-type (hypersensitivity) reaction to XARELTO®
What Should I Tell My Doctor Before or While Taking XARELTO®?
Tell your doctor or dentist about all the medicines you take.
- This includes XARELTO®, any other prescription and nonprescription medicines, over-the-counter medications, and herbal supplements.
Tell your doctor if you:
- Have a bleeding disorder or have problems with unusual bleeding
- Have any problems with your kidneys or liver
- Are pregnant or planning to become pregnant
- Are breast-feeding or are planning to breast-feed
What Are the Possible Side Effects of XARELTO®?
- XARELTO® may increase your chance of bleeding. This bleeding can sometimes be serious (and even life-threatening)
- In studies side effects with XARELTO® included fluid leakage from a wound, itching, pain in arms or legs, blisters, fainting, and muscle spasm.
- Discuss any side effects with your doctor. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN (526-7736)
This is a summary of important information about XARELTO®. If you would like more information, talk with your doctor.
Please see full Product Information, or visit www.XARELTOhcp.com.
1 Patel PR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011.
AED Failures Connected to Deaths from Cardiac Arrest
More than 1,000 cardiac arrest deaths over 15 years are connected to the failure of automated external defibrillators (AEDs); battery failure accounted for almost one-quarter of the failures. The study was published online in the Annals of Emergency Medicine (“Analysis of Automated External Defibrillator Device Failures Reported to the Food and Drug Administration” http://bit.ly/ox6YYr).
“Survival from cardiac arrest depends on the reliable operation of AEDs,” said lead study author Lawrence DeLuca, MD, of the University of Arizona Department of Emergency Medicine in Tucson. “AEDs can truly be lifesavers but only if they are in good working order and people are willing to use them.”
Researchers analyzed reports to the Food and Drug Administration (FDA) about all adverse events connected to use of an AED between January 1993 and October 2008. Of the 40,787 AED-related events reported to the FDA, 1,150 adverse events connected to fatalities were reported. Almost half (45 percent) of failures occurred during the attempt to charge and deliver a recommended shock to the person in cardiac arrest.
Problems with pads and connectors accounted for 23.7 percent of the failures and battery power problems accounted for 23.2 percent of the failures.
Sudden cardiac arrest is a leading cause of death in North America and Europe. Odds of survival decline by 7 to 10 percent per minute of delay in defibrillation. Even as AEDs have proliferated in public places such as airports and offices, bystanders are reluctant to use them. An Annals of Emergency Medicine study published earlier this year found that less than half of people in public places reported being willing to use an AED and more than half were unable to recognize one.
“AEDs are like any other piece of medical equipment: They can experience unexpected failures,” said Dr. Deluca. “I would recommend that people maintain AEDs as recommended by the manufacturer. If an unexpected device failure occurs it is vitally important to promptly contact both the manufacturer and the FDA. Then be sure to return the unit (and accessories such as pads or batteries) to the manufacturer immediately so that it can be analyzed and a cause for the failure identified and fixed.”
Annals of Emergency Medicine is the peer-reviewed scientific journal for the American College of Emergency Physicians, a national medical society. ACEP is committed to advancing emergency care through continuing education, research, and public education. Headquartered in Dallas, Texas, ACEP has 53 chapters representing each state, as well as Puerto Rico and the District of Columbia. A Government Services Chapter represents emergency physicians employed by military branches and other government agencies.
St. Jude Medical Launches the Industry's First Quadripolar Pacing System in India
St. Jude Medical, Inc., a global medical device company, announced the approval of the industry’s first quadripolar pacing system for cardiac resynchronization therapy defibrillators (CRT-Ds) in India. The Promote Quadra™ CRT-D offers physicians the ability to more effectively and efficiently manage the ever-changing pacing needs of patients with heart failure.
Cardiac resynchronization therapy, which can be delivered in an implantable cardioverter defibrillator (ICD) or a pacemaker, resynchronizes the beating of the heart's lower chambers, which often beat out of sync in heart failure patients. Studies have shown that CRT can improve the quality of life for many patients with heart failure. Approximately 23 million people worldwide are afflicted with congestive heart failure (CHF), and two million new cases of CHF are diagnosed each year worldwide.
The quadripolar technology 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 complications without having to expose the patient to additional surgeries. St. Jude Medical is the only company to offer quadripolar pacing.
The Quartet™ left ventricular pacing lead is used as part of the quadripolar pacing system. It is the first lead to feature four electrodes that enable up to 10 pacing configurations. 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 leads that have only 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.
Common pacing complications that can occur in patients implanted with a CRT system include high pacing thresholds and unintentional phrenic nerve or diaphragmatic stimulation. Patients with high pacing thresholds require significantly higher energy to pace the heart; this may reduce the device’s battery life or cause pacing to fail. Phrenic nerve and diaphragmatic stimulation occur when the electrical output from a device inadvertently activates the diaphragm muscle (either directly or via the phrenic nerve), causing hiccups upon each pacing stimulus. Both high pacing thresholds and phrenic nerve or diaphragmatic stimulation are often due to the location of the pacing lead electrode.
“High pacing thresholds and phrenic nerve capture have been major problems with LV leads. This new quadripolar LV lead offers different pacing vectors and helps us to choose a vector which is devoid of Phrenic nerve capture. Altering pacing polarity may offer a lower pacing threshold, which is likely to improve the battery longevity,” said Dr. Calumbur Narsimhan, Director of Arrhythmia-Electrophysiology Services at CARE Hospital in Hyderabad.
The Promote Quadra CRT-D and Quartet pacing lead have both received European CE Mark approval.
FDA Panel to Review AtriCure’s Synergy Ablation System
AtriCure, Inc., a medical device company and a leader in cardiac surgical ablation systems and systems for the exclusion of the left atrial appendage, announced that a U.S. Food and Drug Administration’s (FDA) Circulatory System Devices Panel meeting is scheduled to review AtriCure’s Premarket Approval Application (PMA) for its Synergy Ablation System on October 26, 2011. AtriCure submitted the final module of its PMA in December 2010 for an atrial fibrillation (AF) indication during open-heart concomitant procedures.
About AtriCure, Inc.
AtriCure, Inc. is a medical device company and a leader in developing, manufacturing and selling innovative cardiac surgical ablation systems designed to create precise lesions in cardiac tissue and systems for the exclusion of the left atrial appendage. The company believes cardiothoracic surgeons are adopting its ablation products for the treatment of AF during concomitant open-heart surgical procedures and sole-therapy minimally invasive procedures. AF affects more than 5.5 million people worldwide and predisposes them to a five-fold increased risk of stroke. AtriCure is conducting clinical trials in support of an AF indication. However, to date, the FDA has not cleared or approved AtriCure’s products for the treatment of AF or a reduction in the risk of stroke.