News
- Wed, 12/28/11 - 11:51am
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- 258 reads
Cameron Health Reaches 1,000 Patient Milestone for S-ICD® System
Cameron Health, Inc. announced that the 1,000th patient was recently implanted with the S-ICD® System, the world’s only completely subcutaneous implantable defibrillator.
The 1,000th patient was implanted by Lara Dabiri Abkenari, MD, in association with Professor Luc Jordaens, MD, PhD, at the Erasmus Medical Center in Rotterdam, the Netherlands. Professor Jordaens remarked, “We have gained significant insight into this new technology over the past two years and are encouraged by the results.
Clinical and Industry News
- Sun, 5/2/10 - 8:04pm
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- 4446 reads
AngelMed Guardian System Wins Medical Design Excellence Award
Angel Medical Systems announced that the AngelMed Guardian System has received a 2010 Medical Design Excellence Award. The Guardian is an implantable cardiac monitoring and alerting system that detects rapid ST shifts that may indicate thrombotic coronary occlusions caused by vulnerable plaque ruptures.
The device uses wireless technology to alert patients to seek immediate medical attention.
News
- Mon, 4/5/10 - 9:49pm
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- 1354 reads
Medtronic Receives FDA Panel's Unanimous Recommendation for Approval of Revo MRI™ SureScan™ Pacing System
Medtronic, Inc. announced that the U.S. FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted unanimously in favor of approval with conditions of the Revo MRI™ SureScan™ pacing system designed as MR Conditional, or safe for use in Magnetic Resonance Imaging (MRI) systems under specified conditions.
MRI procedures are not recommended in the United States for patients who currently have implanted pacemakers; if approved, Revo MRI has the potential to be the first FDA-approved pacing system designed for use in the MRI setting.
Industry News and Products
- Wed, 1/6/10 - 9:35am
- 1 Comments
- 2563 reads
Spectranetics Announces FDA Clearance of VisiSheath™ Dilator Sheath, New Lead Management Device
Enhanced Visibility and Performance Features Help Physicians Dilate Scar Tissue Surrounding Problematic Cardiac Leads Requiring Removal
Spectranetics Corporation announced it has received Food and Drug Administration (FDA) 510(k) clearance for its new VisiSheath™ Dilator Sheath device.
This expands the market for VisiSheath, which recently also received CE Mark approval in Europe. The VisiSheath Dilator Sheath may be used alone as an independent sheath for dilating tissue surrounding cardiac leads, or as an enhanced outer support sheath in conjunction with compatible inner sheaths such as Spectranetics’ Laser Sheath (SLS® II), a laser-based system for removing problematic pacing and defibrillator leads.
Industry News and Products
- Thu, 12/3/09 - 12:37pm
- 0 Comments
- 2004 reads
Medtronic Launches Global Clinical Trial Evaluating Outcomes From Comprehensive Attain® Family of Left-Heart Leads and Delivery Catheters
Medtronic, Inc announced the first enrollment in the global Attain Success trial that will evaluate implant success, complication rates and procedure times in the market-released Attain® Family of left-heart leads and delivery systems portfolio.
Fifteen new Attain Family therapy delivery products were commercially released in the last two years, including 13 catheters and two Medtronic-exclusive left-heart leads — Attain StarFix® and Attain Ability®. Safwat Gassis, MD, with Associated Cardiologists at Pinnacle Health Harrisburg Hospital in Harrisburg, Pennsylvania, completed the first enrollment.
Industry News and Products
- Fri, 11/6/09 - 1:04pm
- 0 Comments
- 2131 reads
Biosense Webster Receives FDA Clearance for the Carto® 3 System
State-of-the-Art Navigational Mapping System Offers Unique Combination of Accuracy, Speed and Efficiency
Biosense Webster, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared for marketing the Carto® 3 System, the most advanced three-dimensional imaging technology for use by electrophysiologists in treating cardiac arrhythmias.
It is estimated that 20 million people in the United States suffer from some sort of arrhythmia. Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia, affecting between 2.3 to 5.6 million adults in the United States alone, and is the leading cause of stroke among people 65 years and older.
Industry News & Products
- Thu, 9/24/09 - 8:36am
- 0 Comments
- 1865 reads
Hansen Medical Unveils Next-Generation Robotic Catheter System and Two New Catheters Offering Advanced Navigation Within the Heart
Robotic Irrigated Ablation Catheter for European Union to Offer Stability During Treatment of Atrial Fibrillation
Hansen Medical, Inc. announced it has received U.S. FDA clearance for its next-generation Sensei® X Robotic Catheter System and introduced the Artisan Extend™ Control Catheter. The company also introduced the Lynx™ Robotic Ablation Catheter, a small, flexible irrigated ablation catheter for customers in Europe.
Industry News & Products
- Mon, 9/21/09 - 10:32am
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- 1700 reads
Transoma Medical Announces First Patient Enrollment in Clinical Study to Evaluate Recurrence of Atrial Fibrillation Post Catheter Ablation
Transoma Medical, Inc., manufacturer of Sleuth AT™, a wireless, automated implantable cardiac monitoring system with programmable and frequent electrocardiogram sampling, announced the first patient enrollment and implant in a long-term study to monitor patients who have been prescribed catheter ablation therapy for atrial fibrillation (AF) at risk of recurrence of AF after the procedure.
Industry News and Products
- Wed, 8/12/09 - 3:29pm
- 0 Comments
- 2170 reads
MADIT-CRT Trial Meets Primary Endpoint
Boston Scientific Corporation and the University of Rochester Medical Center announced that the landmark MADIT-CRT trial has met its primary endpoint. Preliminary results show Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) to be associated with a significant 29 percent reduction (p=0.003) in death or heart failure interventions when compared to traditional implantable cardioverter defibrillators (ICDs).
High risk,1 asymptomatic or mildly symptomatic, New York Heart Association (NYHA) Class I and II2 patients were enrolled in MADIT-CRT. The MADIT-CRT Executive Committee expects to present and publish the trial's full results later this year.
Industry News & Products
- Wed, 7/1/09 - 3:44pm
- 0 Comments
- 1768 reads
St. Jude Medical Announces Initial Implant of First-to-Market
Connector System in the U.S.
St. Jude Medical, Inc. announced the first implant of its Current® Plus implantable cardioverter defibrillator (ICD), featuring the SJ4 connector system. The St. Jude Medical SJ4 connector reduces the number of connections between the device and the wires (defibrillation leads) that send electrical impulses to the heart, which is intended to enable a streamlined implant procedure.
The SJ4 connector system features a single connection between the device and the defibrillation lead, and a single set screw (used to tighten and secure the lead to the device). Previous defibrillator lead designs required three separate connections and four set screws. The reduced number of lead connections also lessens the risk of lead-to-can abrasion, a known complication that can occur in patients who have an implantable device.
