Wednesday, March 17, 2010

Dyna-Vision Real-Time Remote Patient Monitoring System Gets US Green Light

RS TechMedic BV out of Broek op Langedijk, The Netherlands has received FDA 510(k) clearance for its Dyna-Vision line of portable cardiac monitors. The devices, already approved in Europe, transmit ECG data wirelessly to a clinician via Bluetooth or through a mobile phone network.

Features of the top end Dyna-Vision device from the product page:

Remote Monitoring of Vital Signs: > 3, 5 and 12 lead ECG > Heart Rate > Plethysmogram & SpO2 > Respiration & Respiratory Rate

Benefits:
> Real-Time Remote Monitoring without limitations
> Internal GSM, Bluetooth Class I and USB connection
> No peripherals required for transmission
> Dyna-Vision© supports all mobile networks

Turn-key Telemedicine Solutions and Interfacing:
> Integration of Dyna-Vision© in existing platforms
> Server Solution, PC software and monitoring devices
> Remote Cardiac Diagnostic Services

Here's a demo video about Dyna-Vision:

Product page: Dyna-Vision...

Here's an interview Ivor Kovic, our former editor, took with the CEO of RS TechMedic in October 2008: Dyna-Vision Monitoring from RS TechMedic...

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Tuesday, March 16, 2010

SJM Enhances Usability of Company's FFR Measurement Technology

St. Jude Medical has announced a few additions and improvements to their Fractional Flow Reserve (FFR) measurement system. The PressureWire Certus FFR measurement device is promised to be more ergonomic for physician use, while PressureWire Aeris, the wireless version, can now be used with Siemens AXIOM Sensis XP hemodynamic recording system.

The new PressureWire Certus includes modifications to design and functionality which will provide physicians with more controlled handling and versatility. It is the only guidewire on the market to offer in one wire the combined measurement of pressure and temperature which enables calculations of FFR, Coronary Flow Reserve (CFR) and an Index of Microcirculatory Resistance (IMR).

The PressureWire Aeris system offers a secure, wireless interface between PressureWire and a cath lab's hemodynamic recording system to immediately display, measure and save FFR data. With FFR results integrated into a patient's existing study record, the severity of coronary lesions is documented together with other procedural data and angiographic imagery. The wireless technology of the PressureWire Aeris also eliminates cables crossing the sterile field, reducing variables and making the entire procedure faster and easier.

St. Jude Medical's new agreement with Siemens will enable integrated wireless FFR measurement with PressureWire Aeris as an upgrade to hospitals using the Siemens AXIOM Sensis XP. The AXIOM Sensis XP is one of the most widely used hemodynamic recording systems in cath labs and offers advanced measurement programs which aid physicians in interventional procedures.

Because of this new agreement with Siemens, and existing compatibility with other recording systems including the GE Mac-Lab(R) Hemodynamic Recording System, Mennen Horizon XVu and the McKesson Horizon Cardiology Hemo(TM) solution, the PressureWire Aeris technology can be used in the majority of cardiac cath labs for wireless integrated FFR measurement utilizing existing hardware.

Press release: St. Jude Medical Announces Multiple Enhancements to Industry-Leading PressureWire FFR Measurement System ...

Product pages: PressureWire™ Certus FFR Measurement System; PressureWire™ Aeris Wireless FFR Measurement System...

Flashbacks: New Technology Reduces Risks After Cardiac Stenting Procedures; RADI and GE Healthcare Collaboration Delivers First Wireless FFR Monitoring ;

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Abbott's Bioresorbable Stent Continues to Prove Itself in Trials

At the American College of Cardiology's 59th annual scientific session in Atlanta this week, Abbott released results of a Phase 2 clinical trial of its bioresorbable vascular scaffold (BVS). In this 30 day trial, the new stenting technology has led to no thrombosis, no ischemia-driven target lesion revascularization, and a rate of major adverse cardiac events was only 2 percent.

From the announcement:

This second phase of the ABSORB clinical trial (Cohort B) enrolled 101 patients from 12 centers in Europe, Australia and New Zealand, and incorporates device enhancements designed to improve deliverability and vessel support.Abbott is the only company with long-term, three-year clinical data on a complete patient set evaluating the safety and performance of a fully bioresorbable drug eluting scaffold.

Abbott's investigational BVS is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as dissolving sutures. The bioresorbable technology is designed to restore blood flow by opening a clogged vessel and providing support until it is healed. Once the vessel can remain open without the extra support, the bioresorbable scaffold is designed to be slowly metabolized by the body, and is completely dissolved over time. Since a permanent implant is not left behind, a vessel treated with BVS has the ability to ultimately move, flex and pulsate similar to an untreated vessel. The potential to restore these naturally occurring vessel functions, or vascular restoration therapy, is what makes Abbott's BVS unique in the field of cardiology.

Press release: Abbott Announces Positive Data From ABSORB Trial on Its Bioresorbable Vascular Scaffold Technology...

Flashbacks: Abbott's Bioabsorbable Stent Showing Promise at Three Years ; Abbott's Bioabsorbable Stent Earns High Marks in Clinical Trial; Abbott Reports Positive Data from Study of Its Bioabsorbable Drug Eluting Stent; Bioabsorbable Stents: So Far So Good

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Friday, March 12, 2010

SJM's New Engage and Engage TR Catheter Introducers

St. Jude Medical has announced receipt of FDA and European regulatory approvals for the Engage and Engage TR line of introducers for cardiac catheterization procedures. The firm believes the new products' design will facilitate safer arterial access and subsequent closure following the procedure.

St. Jude Medical designed the Engage Family of Introducers with features intended to minimize trauma to the artery and set the stage for closure using Angio-Seal(TM) or other closure devices.

The Engage Family of Introducers was designed to create a smooth and reliable means of accessing vasculature for a wide variety of patients and procedures. The Engage Introducer is used for femoral access, in which physicians access the patient's heart through the femoral vein or artery located near the groin; this portfolio includes 22 model configurations of varying sizes to accommodate a wide variety of procedures. The Engage TR Introducer portfolio includes 18 model configurations and expands the company's product offering to include introducers used to facilitate transradial (TR) procedures, in which physicians access the patient's heart through the radial artery in the arm.

Though uncommon, some risks reported by physicians during interventional and diagnostic procedures include bleeding, vessel trauma, vasospasm (a condition that causes the vessel to constrict), or formation of blood clots within the introducer. The Engage Family of Introducers incorporates new features that were designed to offer physicians more control and minimize these risks both during access and throughout the procedure.

Press release: New Introducer Product Line from St. Jude Medical Offers Reliable Access and Facilitates Arterial Closure ...

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Wednesday, March 10, 2010

Stentys Self-expanding Coronary Bare-Metal Stent System for Unusual Vessels

Stentys Inc. of Paris, France has received the CE Mark of approval to take to the European market the firm's self-expanding coronary stent. The bare-metal system has been developed to allow physicians to work on coronary arteries that have an uneven diameter in the treatment area and when large branch vessels are involved.

From the product page:

The stent’s short, expandable segments and its self-expansion features allow for excellent vessel conformability as well as continuous apposition along the arterial wall, superior to existing balloon-expandable stents as demonstrated through IVUS and OCT imaging. The gentle expansion forces are well suited for deployment in an artery with a heavy clot burden, like in acute settings.

The Stentys stent is designed with small distinctive interconnectors that can be used to create an opening through the stent mesh. It allows the clinician to safely navigate and deploy the stent, then disconnect the stent connectors with an angioplasty balloon to provide side branch access independent of branch ostium location : the connectors are placed all along the length and the circumference of the stent.

Press release: Stentys self-expanding stent receives CE Marking to treat acute coronary syndrome (ACS) ...

Stentys technology platform...

Brochure: Self-expanding Coronary Bare-Metal Stent System... (.pdf)

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Tuesday, March 9, 2010

Continuous Left Atrial Pressure Monitoring Helps With Management, Outcomes in CHF Patients

St. Jude Medical is touting results of a recently published study that analyzed the clinical benefits of frequent and regular left atrial pressure (LAP) monitoring in patients with heart failure. In the study, patients wore a special device, called HeartPOD, that monitored their LAP and routed the data wirelessly to their cardiologist. The physician, in turn, was able to adjust the prescription drug dosage taken by the patient on a daily basis. The results show that this leads to better overall outcomes for patients and a greater understanding of the condition for the physicians involved.

The above picture was given to us by St. Jude Medical. And we think it has a clue as to the future of this technology. Imagine this kind of monitoring shows more and more positive outcomes in the future clinical studies, and it wins all needed regulatory approvals. One day we might be seeing these pressure monitoring sensors embedded into the electrodes of AICDs and pacemakers. Wouldn't that be neat?

Results from this study demonstrated that regular monitoring of LAP in combination with a dynamically adjusted prescription plan can be used to drive appropriate adjustment of HF treatments, and as a result, improved LAP control and reduction of HF events that may result in hospitalization or death.

Following implantation of an LAP sensor, all subjects in the study were free of major adverse cardiac and neurological events at six weeks, meeting the trial's primary endpoint. Over a median follow-up of 25 months, LAP control was achieved for at least six consecutive months in 76 percent of patients, with a 67 percent reduction in the frequency of elevated LAP readings (over 25 mmHg). Throughout this same period, there was a significant 84 percent average decrease in HF events including HF hospitalization and all-cause mortality once LAP-guided therapy was initiated. Over the course of treatment, patients also had significant improvements in HF symptoms and quality of life.

The report outlined results of the first 40 patients enrolled in the trial; 20 patients enrolled in three Australian or New Zealand sites and 20 patients enrolled in four U.S. sites.

The early results of the HOMEOSTASIS trial led to the establishment of the LAPTOP-HF (Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy) Study, a larger pivotal, randomized, controlled, prospective, multi-center clinical investigation. The LAPTOP-HF study will be conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) and is expected to begin in the first half of 2010.

Abstract in Circulation: Physician-Directed Patient Self-Management of Left Atrial Pressure in Advanced Chronic Heart Failure

Press release: St. Jude Medical Announces Publication of Feasibility Results for Trial of Novel Heart Failure Management System ...

Medgadget 2005 flashback: HeartPOD...

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COR Analyzer for Automatic Identification of Coronary Stenoses

Rcadia Medical Imaging out of Haifa, Israel won European approval for the COR Analyzer software for identifying coronary artery stenosis from coronary CT angiography (cCTA) data. The app runs on standard PCs and will automatically process CT angiogram studies sent to it over the hospital network. The application then replies whether it identified a stenotic legion, pointing out to radiologists or cardiologists the area of concern.

Here's the application workflow and features of the COR Analyzer:

Isolate the heart region within a study

Find major anatomical structures

Locate the coronary artery tree and track the arteries

Label coronary artery segments

Segment the blood vessel internals and draw an accurate center line

Detect severe stenotic lesions

Findings can be easily verified and validated using simple visualization tools including standard 2-D projections, schematic 3-D and curved MPR views. The system automatically generates a report which includes a summary of findings and curved MPR snapshots. It can be easily edited by the physician to produce the final report.

The automatically generated curved MPR images with marked detected lesions can be exported to any PACS/Workstation either manually or automatically upon completion of processing. These images will appear as secondary capture series for the corresponding study.

Main features

Detects of significant coronary lesions

Displays 3D coronary tree & curved MPRs

Generates patient findings' reports

Exports to PACS and workstation

Runs on any 64-slice or higher CTA scanner

Product page: COR Analyzer System ...

Press release: Rcadia Medical Imaging's COR Analyzer(R) System Receives CE Mark ...

(hat tip: MassDevice)

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Friday, March 5, 2010

Syncardia's Freedom Mobile Artificial Heart Driver Gets CE Mark

SynCardia of Tucson, AZ, maker of the CardioWest Total Artificial Heart, has received European approval for the Freedom wearable driver. The device allows patients to get off the "Big Blue" driver that powers their heart in the hospital after implantation, and regain a sense of mobility while on wait for a permanent donated organ. It's not clear how long the batteries last before requiring a recharge.

From the announcement:

SynCardia hospital drivers support patients from Total Artificial Heart implant until their condition stabilizes. Once stable, European patients will be switched to the Freedom driver and discharged from the hospital to wait for their matching donor heart at home.

The Freedom driver weighs 13.5 lbs including two onboard lithium ion batteries and a power adaptor. It can be conveniently carried by the patient in the Freedom Backpack or Shoulder Bag. The Freedom driver is 60% lighter than SynCardia’s older CE approved “proof of concept” portable driver, which weighs approximately 35 lbs and is transported in a wheeled caddy.

The Freedom driver uses a “dark cockpit” design philosophy for simple and easy operation. Similar to an airplane cockpit, the system only flashes a light or sounds an alarm when something requires the user’s attention.

To make maintenance easier for hospitals, the Freedom driver is serviced by replacement via express delivery. No onsite repair or inventory of parts is required by the hospital.

Press release: Freedom Driver System Receives CE Mark to Power SynCardia's Total Artificial Heart in Europe ...

Flashbacks: Medgadget's SynCardia archives...

Images courtesy of syncardia.com.

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Tuesday, February 16, 2010

Will Microvolt T-Wave Alternans Be Incorporated Into Other Devices?

Cambridge Heart, Inc., a Tewksbury, Massachusetts firm, is reporting that it has completed the development of an OEM (original equipment manufacturer) module of its Microvolt T-wave Alternans (MTWA), and is now seeking FDA's 501(k) to start marketing its technology. According to MassDevice, the company is planning to shift its focus from sales to physicians and hospitals, so it can now start developing "an OEM version that other manufacturers could incorporate into their own products."

As some of you might remember from our previous coverage of this technology, the Microvolt T-wave Alternans (MTWA) stress test, that "looks at beat-to-beat fluctuation in the amplitude of the T-wave at a microvolt level," was initially developed by MIT with support from NASA's Johnson Space Center and the National Space Biomedical Research Institute in Houston, Texas. The technology has shown promise in a number of studies by predicting increased patient risk to develop life threatening ventricular arrhythmias or sudden cardiac arrest. One example of this would be positive results from the Alternans Before Cardioverter Defibrillator (ABCD) trial, that were presented at the American Heart Association's 2006 Scientific Sessions (1).

It will now be interesting to see if major manufacturers try to incorporate MTWA technology into their monitors, and whether MTWA will make inroads into other clinical areas, such as advanced perioperative anesthetic or critical care monitoring, or preoperative evaluation.

Here's more about the MTWA technology:

Microvolt T-Wave Alternans is defined as an alternation in the morphology of the T-wave in an every other beat or AB-AB pattern. It has long been associated with ventricular arrhythmias and sudden death. First recognized nearly a century ago, visually discernible alternans were linked to the rapid onset of ventricular tachyarrhythmias.

Research conducted in the early 1980's by Dr. Richard Cohen and his colleagues at MIT explored the idea that visually indiscernible alternans may be equally significant. These efforts established a link between visually imperceptible alternans at the microvolt level and susceptibility to arrhythmias and showed alternans to be a heart rate dependent phenomenon. In addition, they developed a methodology, known as the Spectral Method, which allowed measurement of alternans at the level of one microvolt.

This method was refined to create our proprietary Analytic Spectral Method® which uses Micro-V Alternans Sensors™ that are specially designed, high-resolution, noise canceling sensors to detect minute heartbeat variations, measured at as little as one-millionth of a volt. This permits the measurement of alternans even in the presence of the noise typically encountered during exercise stress testing. These sensors allow the recording of up to four ECG signals from the same anatomical site as well as electrode-skin impedance and respiratory signal. An adaptive noise reduction algorithm combines these signals to create an enhanced ECG signal to expose previously indiscernible T-Wave alternans.

The Microvolt T-Wave Alternans test is a provocative, non-invasive, easy to perform, diagnostic test. By taking detailed ECG measurements during rest, exercise, and then rest again, the HearTwave® II System can identify the presence of Microvolt T-Wave Alternans.

In most situations, the test takes less than 30 minutes to perform. Following the placement of fourteen sensors - 7 Micro-V Alternans Sensors and 7 standard electrodes - in the Frank-lead configuration, the electrodes are connected to the digital ECG amplifier that leads back to the Microvolt T-Wave Alternans enabled system. At the beginning of the test, the patient is directed to begin walking on a treadmill to raise the heart rate. Patients who are unable to exercise can have their heart rates elevated pharmacologically to achieve the higher rate needed for a successful test.

Full story: Cambridge Heart asks FDA for 510(k) clearance for OEM device...

Press release: Cambridge Heart Completes Development of New MTWA Module ...

Product page: HearTwave® II Microvolt T-Wave Alternans™ System ...

Technology info page: Microvolt T-Wave Alternans ...

Flashbacks: Microvolt T-Wave Alternans Testing Shows Promise for Predicting Sudden Cardiac Death; HearTwave® II Microvolt T-Wave Alternans System ;

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GE's Vscan, World's Smallest Portable Ultrasound, Now Available Worldwide

GE Healthcare is finally releasing the much awaited Vscan pocket sized ultrasound. Many in the industry hope that this device offers a chance for physicians to make a move from stethoscopes to portable imaging devices, bringing advanced visualization to any examination room. The unit weighs one pound and is only 3 inches (7.6 cm) wide and 5.3 inches (13.5 cm) long, offering both standard black and white imaging, as well as colored blood flow doppler. GE is touting Vscan's size and capabilities for cardiologists to transthoracically view myocardium, pericardium, and heart valves, and for primary care physicians, as well as OB, ER, and others, to scan the liver, kidney, aorta and peripheral vessels, babies in the womb, and anything else the transducer can penetrate.

Features from the product FAQ:

An online portal provides Vscan users with training tools for the product and basic clinical
applications with sections about imaging technique, anatomy and trouble shooting

Intuitive user interface that can be controlled using the thumb

Intelligent workflow enhancements

Battery charger station and battery life of one hour scanning - good for up to 30 patients based on
average of 2 minutes per scan

Voice annotation

USB docking station

Link to a PC for organization and export of data

Gateway software with services tools and remote diagnostics

Here's our video from a GE event introducing the Vscan:

Press release: GE Healthcare Introduces Vscan™ Pocket-sized Visualization Tool for Point-of-care Imaging

Product page: Vscan ...

Flashbacks: A Closer Look at GE's Vscan Pocket Ultrasound ; More Details About The New GE Vscan Ultrasound System; GE's New Ultra Small Ultrasound May Become as Ubiquitous as Stethoscope

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Thursday, February 11, 2010

FDA Approves World's Most Powerful Cardiac Resynchronization Therapy Defibrillator

Sorin Group (Milan, Italy) has announced U.S. FDA approval and first implant of its next-generation of cardiac resynchronization therapy defibrillator (CRT-D), Paradym CRT Model 8750. According to the company, this is the world's most powerful AICD, with a 37 Joule punch:

Paradym™ offers consistent charge times throughout the life of the device (10s at Beginning Of Life, 13s at Elective Replacement Indicator - ERI), improved longevity, and a 6-month ERI to End of Service (EOS) period, twice as long as any other ICD.

Paradym™ CRT is designed to allow more flexibility in the management of cardiac resynchronization and antitachyarrhythmia therapy in heart failure patients. BTO (Brady-Tachy Overlap) is designed to unlock pacing and detection to ensure delivery of resynchronization therapy at high pacing rates during exercise without any compromise on the management of slow ventricular tachycardias (VTs). BTO gives freedom of programming for physicians.

Paradym™ CRT, at 34cc and 11mm thin, also features the PARAD®+ detection algorithm whose superior specificity in discriminating ventricular arrhythmias has been clinically proven. Studies have demonstrated that the absolute risk of experiencing an inappropriate shock has been observed to be only 5%, the lowest percentage recorded thus far.

Press release: SORIN GROUP ANNOUNCES MARKET RELEASE AND FIRST IMPLANT OF NEXTGENERATION CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR...

Product page: PARADYMTM CRT 8750 ...

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Wednesday, February 10, 2010

CardioInsight's Noninvasive 3D EP Mapping Technology

CardioInsight Technologies Inc., a company headquartered at University Hospitals of Cleveland, has recently closed a $6 million Series B round of funding for further development of its cardiac Electrocardiographic Mapping (ECM) technology. Designed to improve the detection and 3D visualization of ectopic foci in arrhythmia patients, the company's technology "combines body surface electrical data with heart-torso anatomical data to provide 3-D images of electrical activity for the entire heart, non-invasively and simultaneously." The firm believes its patented technology, that combines body surface electrical data from a chest sensor array with detailed anatomical data from CT scans, can offer beat by beat EP mapping of the heart:

CardioInsight’s electrocardiographic mapping technology gathers electrical information about the heart from an electrode ‘vest’ placed on a patient’s body and combines it with images from a CT scan to provide 3D maps of the electrical activity of the heart. Unlike conventional methods, CardioInsight’s technology is non-invasive and provides beat-by-beat whole heart mapping. The technology’s strengths in guiding the treatment of arrhythmias and heart failure have been demonstrated in more than 125 pre-procedural and intra-procedural patient studies at clinical centers including University Hospitals of Cleveland, Loyola Chicago, and Hôpital Cardiologique du Haut–Lévèque in Bordeaux, France.

CardioInsight technology and product...

Press release: CardioInsight Technologies Closes $6 Million Funding Round...

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Friday, February 5, 2010

St. Jude Medical Gets Go Ahead for New Implantable Cardiac Devices

St. Jude Medical has received the European CE Mark of approval for the Fortify and Fortify ST implantable cardioverter defibrillators (ICD) and Unify cardiac resynchronization therapy defibrillator. The devices are smaller and can deliver a stronger punch than previous generation models, and they feature new heart monitoring algorithms.

These devices feature 40J of delivered energy (45J stored) - the highest energy level available in the industry - helping to ensure that therapy will be successful for those patients who require a higher energy shock for defibrillation.

Because of the devices' narrower shape, physicians can implant them using a shorter incision, leading to less time spent closing the incision and a smaller scar for the patient. The company's SJ4 lead connector system further streamlines the procedure by reducing 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 Unify CRT-D and Fortify ICD also incorporate the new CorVue(TM) pulmonary congestion monitoring algorithm. This new feature alerts physicians when a patient's heart failure may be worsening, as evidenced by changes in electrical signals that can be correlated to increased congestion, or fluid retention, in the chest area. The algorithm continuously monitors fluid retention in multiple vectors, providing an accurate diagnostic and an alert designed to minimize false positives.

Both devices also have features that are designed to assist in the reduction of unnecessary shocks, including painless anti-tachycardia pacing, which can be used for fast ventricular arrhythmias prior to or while the device is preparing to deliver shock therapy, and other enhanced technology for reducing inappropriate therapy.

In addition to the family-wide features of the Unify and Fortify devices, the Fortify ST ICD features St. Jude Medical's first-to-market ST segment monitoring diagnostic algorithm, which can add important information to assist in medical decision making and accelerate patient care. The Fortify ST ICD continuously monitors for specific changes in the ST segment of the electrocardiogram that can indicate the onset of serious conditions such as ischemia.

Press release: St. Jude Medical Announces European Approval of Smaller, Higher Power ICD and CRT-D Devices with New Heart Failure Monitors

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Thursday, February 4, 2010

Toshiba's Viamo Ultrasound Now Available in US

Toshiba won FDA approval to market the Viamo portable ultrasound, a convertible touchscreen device that the company promises provides the same image quality as premium cart systems. The package comes with a wheeled pole that can carry the Viamo and additional transducers for easy exchange.

From the product page:

Sharing its core imaging engine and transducer technology with Aplio XG, Viamo offers high-end image quality also in situations where unlimited portability is required.

Its full range of high-performance imaging functions lets you visualize minute tissue details and vascular structures with precision for a faster, more accurate diagnosis. Advanced imaging functions such as Pulse Subtraction THI come standard with Viamo.

Viamo’s built-in touch screen allows for seamless workflow and an outstandingly comfortable and intuitive operation of the system. Viamo’s monitor can be rotated to enable free positioning of the screen. When fully turned and folded flat, Viamo can be operated in tablet mode solely via its touch screen. Individual key functions on Viamo’s console and touch screen are user programmable to suit your specific diagnostic requirements or personal preferences.

A whole range of workflow automation functions is available on Viamo. One-touch QuickScan for instance helps you achieve better imaging results in less time by automatically optimizing your imaging parameters. And Viamo’s innovative SonoSet™ function alows you to carry out examinations conveniently by simply executing freely programmable protocols step by step.

The battery-powered system is operational within just a few seconds when opened, making it instantaneously available also in critical situations.

Press release: TOSHIBA RECEIVES FDA CLEARANCE FOR VIAMO ULTRASOUND SYSTEM...

Product page: Viamo...

Product brochure...

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Wednesday, February 3, 2010

Duo Ablation Catheter Going on Trial

The FDA has cleared St. Jude Medical to initiate a clinical trial of the company's Duo irrigated ablation catheter for treatment of atrial fibrillation. The device, which already has the European CE mark, features twelve irrigation ports that should provide better cooling of the electrode during ablation.

The IRASE AF trial is the industry's first and the largest head-to-head IDE trial studying irrigated ablation catheters, which use radiofrequency (RF) energy in a non-invasive procedure to destroy abnormal heart tissue. The trial will randomize patients 1:1 between the company's Duo 12 port open irrigated catheter ablation system and an irrigated catheter ablation system that has been approved by the FDA for the treatment of paroxysmal AF, a type of AF that begins suddenly and ends spontaneously. The trial is expected to take about three years to complete and will take place in both the U.S. and international markets with 324 patients.

When the first line of therapy for the treatment of paroxysmal AF using antiarrhythmic medication is ineffective, RF ablation is currently recommended as a second line of therapy for long-term cardiac arrhythmia control. The IRASE AF pivotal study intends to determine whether or not ablation using the company's Duo 12 port open irrigated catheter system is safe and effective compared to the other market approved catheter for treatment of symptomatic paroxysmal AF. It will also determine if the ablation catheter can be indicated for the treatment of symptomatic paroxysmal AF.

The trial's primary efficacy endpoints are targeted pulmonary vein isolation (acute) and freedom from symptomatic AF for 12 months (chronic) following the procedure. The primary safety endpoints are freedom from acute major adverse events within seven days of the procedure and chronic major adverse events within 12 months.

Press release: St. Jude Medical Announces IRASE AF Clinical Trial to Evaluate Cardiac Ablation Catheter System for Treatment of Atrial Fibrillation...

Product page: Therapy Cool Path Duo...

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Tuesday, February 2, 2010

TactiCath Pressure Sensing Ablation Catheter Soon Available in Europe

When cardiac electro-physiologists are burning off cardiac tissue during catheter ablative procedures, they don't really know for sure how much force they are actually applying. This can lead to burning off more than just the ectopic focus. To deal with the problem, Endosense out of Geneva, Switzerland has developed, and last May received European approval for, the TactiCath force-sensing ablation catheter. Now the company has signed a distibution agreement for BIOTRONIK (Berlin, Germany) to release the device to the cath lab market across the world, save for Japan and United States.

Some features of the TactiCath:

Integrated with Touch+ fiber optic sensor technology

Real-time and highly accurate tip-to-tissue contact force measurements

Measurement and display of tip-to-tissue angles and orientation

3.5 mm open irrigated tip

Shaft: 7 F, usable length 115 cm

Tip electrode: 3.5 mm, open irrigated

Electrode Spacing: 2-5-2 mm

Curve Shape: D curve, 65 mm

Press releases: BIOTRONIK and Endosense Sign International Exclusive Distribution Partnership...; ENDOSENSE RECEIVES CE MARK FOR TACTICATH FORCE-SENSING ABLATION CATHETER...(.pdf)

Product page: TactiCath...

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Thursday, January 28, 2010

Impella Heart Pump to Get Intracardiac Pressure Sensor

The next iteration of Abiomed's Impella heart assist pump may be getting an optical pressure sensor built by Opsens of Quebec, Canada. A partnership just announced between the two companies includes plans to integrate Opsens' fiber optic sensors into the Impella to help clinicians monitor intracardiac/intraarterial pressure in real time.

From the press release:

Through this latest enhancement, Opsens' fiber optic sensors will be integrated into the Impella catheter and will allow for further improvements in set-up time, as well as provide a high-quality pressure monitoring capability that can eventually be used to help automate the control and operation of the Impella pump. Unlike current fiber optic sensors used on other cardiac assist devices today such as certain Intra-Aortic Balloons (IABs), Opsens' fiber optic sensor is designed to provide longer-term accuracy and reliability.

Features and benefits of the pressure technology from an Opsens brochure:

High fidelity pressure measurements with no hysteresis, motion artifact, and signal drift

High frequency response preserves signal integrity and prevents damping of signal

Lesser invasive catheterization practices with catheter size reduction

Increase functionality with immunity to MR, RF, MW, EM and electro surgery environments

Easy integration without complicated wire harness leads to manufacturing cost reduction and high production yield

Press release: Abiomed Announces Partnership with Opsens to Utilize Sensor Technology for Impella...

Link: Opsens' cardiovascular blood pressure monitoring technology...

Opsens' fiber optic pressure sensor brochure...

Impella flashbacks: Video of Impella 2.5 Heart Assist Pump Used in Minimally Invasive Procedure; Abiomed Reports New Positive Impella 2.5 Results; Impella 2.5 Heart Pump Performs Well in a Feasibility Trial; Impella 2.5 Heart Pump Given Green Light in US; Impella Percutaneous VAD to be Studied for Acute MI Patients

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Wednesday, January 27, 2010

3D Rotational Coronary X-Ray Angiography On Track for Clinical Use

As medical imaging is rapidly moving toward 3D visualization, angiographies are about to follow suit. A new technique, that uses a rotating X-ray machine, reconstructs images taken from different angles into a volumetric view of the vascular lumen. The initial study using a sole human subject now paves way to see if the technique is actually useful in a more substantial clinical trial.

From the study abstract in Circulation: Cardiovascular Interventions:

A recently developed method to create 3D images of the coronary arteries uses x-ray projection images acquired during a 180° C-arm rotation and continuous contrast injection followed by ECG-gated iterative reconstruction. This method shows promise for providing high-quality 3D reconstructions of the coronary arteries with no user interaction but requires clinical evaluation.

The reconstruction strategy was evaluated by comparing the reconstructed 3D volumetric images with the 2D angiographic projection images from the same 23 patients to ascertain overall image quality, lesion visibility, and a comparison of 3D quantitative coronary analysis with 2D quantitative coronary analysis. The majority of the resulting 3D volume images were rated as having high image quality (66%) and provided the physician with additional clinical information such as complete visualization of bifurcations and unobtainable views of the coronary tree. True-positive lesion detection rates were high (90 to 100%), whereas false-positive detection rates were low (0 to 8.1%). Finally, 3D quantitative coronary analysis showed significant similarity with 2D quantitative coronary analysis in terms of lumen diameters and provided vessel segment length free from the errors of foreshortening.

Fully automated reconstruction of rotational coronary x-ray angiograms is feasible, produces 3D volumetric images that overcome some of the limitations of standard 2D angiography, and is ready for further implementation and study in the clinical environment.

Abstract in Circulation: Cardiovascular Interventions: Clinical Feasibility of a Fully Automated 3D Reconstruction of Rotational Coronary X-Ray Angiograms

Aerican Heart Association press statement: New software provides 3-D views of arteries in catheterization lab...

Image credit: Lisbon Center for Images in Science and Art

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Tuesday, January 26, 2010

Corventis Gets US OK for Wireless Cardiac Arrhythmia Monitoring System

Corventis out of San Jose, CA won FDA 510(k) approval to market the NUVANT Mobile Cardiac Telemetry (MCT) System. The company's wireless technology revolves around the chest worn PiiX electrocardiograph, a high precision single lead ECG, which sends readings to a mobile phone based device for further transmission of the data to a hosted application for clinician's access.

The NUVANT Mobile Cardiac Telemetry System is the second product launched from the Corventis portfolio of wireless cardiovascular solutions. Designed with a specific focus on ambulatory arrhythmia monitoring, the NUVANT MCT System leverages the low profile form factor, advanced algorithms and multi-sensor capabilities of the PiiX wearable platform to enable continuous monitoring for a broad set of arrhythmias, including atrial fibrillation, as well as patient falls that may be associated with arrhythmias. Patients can also trigger the collection of an electrocardiogram (ECG), on-demand, upon experiencing symptoms, further aiding in the correlation of symptoms with the ECG.

All ECGs are promptly transmitted to the Corventis Monitoring Center via the wireless-enabled zLink, for review and response by trained cardiographic technicians. Physicians receive prompt notification of urgent events as well as actionable information in the form of Episode Reports, Daily Reports and End of Use Reports via fax, email and/or the secure www.corventis.com website. Using this information, a physician can diagnose symptomatic and asymptomatic cardiac arrhythmias and proactively manage patients remotely from anywhere across the globe.

Press release: CORVENTIS ANNOUNCES FDA CLEARANCE AND US LAUNCH OF THE NUVANT™ MOBILE CARDIAC TELEMETRY SYSTEM...

Product page: NUVANT™ Mobile Cardiac Telemetry (MCT) System

Flashbacks: Piix Wireless Home Cardiac Monitoring to Undergo Randomized Trial; PiiX Monitors for Signs of Decompensated Heart Failure

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» Sensation Cardiac 64 (August 9, 2005)

» Musings on the Philips HeartStart (July 7, 2005)

» Circulatory System on a Chip (July 5, 2005)

» Simultaneous Hybrid Procedure for CAD (July 5, 2005)

» Benephit for Targeted Renal Drug Delivery (June 28, 2005)

» Guidant Recalls 50,000 Implanted Defibrillators (June 20, 2005)

» The Sunshine Heart C-Pulse (May 23, 2005)

» Ready System allows Mini-Bypass (May 19, 2005)

» Androscope i-stethos Advanced Electronic Stethoscope (May 18, 2005)

» IntelliVue Telemetry System (May 17, 2005)

» HyperQ™ (May 16, 2005)

» Under Construction: 4D Ultrasound System (May 13, 2005)

» VerifyNow™ Aspirin System (May 11, 2005)

» Medtronic CareLink® Programmer - Model 2090 (May 5, 2005)

» AbioCor: It's For a Good Cause (April 25, 2005)

» The SonoSite® MicroMaxx™ (April 20, 2005)

» Underground Medgadgets (April 20, 2005)

» Non-pacing Electric Stimulation for Heart Failure (April 19, 2005)

» The EKG, Untangled (April 12, 2005)

» Brilliance 64-slice CT Scanner by Philips (April 4, 2005)

» Novel Device for High Blood Pressure Implanted (April 1, 2005)

» Optical Coherence Tomography: Positive Results in Clinical Study Reported (March 31, 2005)

» TherOx ® AO System for Hyperbaric Oxygen Delivery (March 25, 2005)

» TriActiv ® Balloon Protected Flush Extraction System (March 22, 2005)

» Pacemaker study sees increase in heart failure rates (March 15, 2005)

» Acuson AcuNav 8F for Intracardiac Ultrasound Exams (March 10, 2005)

» Vasotrac Non-Invasive Blood Pressure Monitor (March 9, 2005)

» GE's LightSpeed VCT System (March 8, 2005)

» Endeavor ™ Drug Eluting Stent: Positive Results Reported (March 7, 2005)

» Biograph 64 PET/CT System (March 4, 2005)

» DynaCT C-arm System (March 4, 2005)

» New ultrasound technique reported (March 3, 2005)

» GuardWire fails in international study (March 2, 2005)

» UltraStethoscope™ (February 21, 2005)

» CardioVision MS-2000: predicting a heart attack in the next 10 years? (February 16, 2005)

» VentrAssist LVAS (February 9, 2005)

» New procedure for children with LQTS (February 3, 2005)

» Philos II DR-T from Biotronik (February 2, 2005)

» INR@Home (January 21, 2005)

» InSync Sentry: defibrillator and CHF monitor (January 17, 2005)

» New Linear ™ 7.5 Fr. Intra-Aortic Balloon (January 11, 2005)

» Signals From Deep Inside (December 28, 2004)

» The LifeVest Conspiracy (December 28, 2004)

» ReadMyHeart ECG (December 17, 2004)

» Personal Health Status Monitor (December 16, 2004)

» BioZ Dx (December 15, 2004)

» Q-Stress® version 3.5 (December 14, 2004)

» Endo-PAT2000 System (December 14, 2004)

» T-Line Tensymeter (December 11, 2004)

» iE33 by Philips (December 11, 2004)

» Vivid i (December 11, 2004)

» Stereotaxis (December 10, 2004)

» Native TEQ Dynamic Technology for ACUSON Sequoia; 8V3 Transducer (December 10, 2004)

» Toshiba Aplio xV (December 10, 2004)

» Titan (December 9, 2004)