Wednesday, May 7, 2008
Boston Scientific ALTREA Pacemaker EU Approved
Boston Scientific just received approval from the EU to market the company's newest family of pacemakers.
The following features are listed in the press release:
ALTRUA is Boston Scientific's most advanced pacemaker and delivers enhanced therapies while maintaining its small size and battery longevity. It is the first Boston Scientific-branded pacemaker to treat bradycardia, a condition in which the heart beats too slowly -- usually less than 60 beats per minute -- depriving the body of sufficient oxygen.Multiple Atrial Ventricular (AV) Delay programming options: These options are designed to reduce unnecessary right ventricular (RV) pacing, without dropping ventricular beats, a key distinction from other competitive RV pacing algorithms. The ALTRUA 50 and 60 series also include an enhanced AV search hysteresis feature, now with an extendable AV delay out to 400 milliseconds, providing physicians with additional flexibility to tailor device programming for unique patient needs. Minute Ventilation (MV) Blended Sensor: This proprietary technology treats a condition called Chronotropic Incompetence, which is the inability of the heart to regulate its rate appropriately in response to physical activity and emotional stress. Boston Scientific's MV Blended sensor is the only sensor that has been shown to restore Chronotropic Competence. Ventricular Rate Regulation (VRR): This feature helps physicians manage patients with frequent atrial arrythmias. Automatic Capture: This capability is designed to offer automatic, safe and accurate ventricular pulse management. The device checks every heart beat to see if the lower chambers of the heart contract in response to the delivered pulse. If no contraction is detected, a backup pace with more energy is delivered.
News release: Boston Scientific Announces European Approval and Market Launch of New Family of Advanced Pacemakers
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Monday, April 28, 2008
InfraReDx Technology: Near Infrared Diffuse Spectroscopy for Coronary Artery Disease
InfraReDx, Inc, a privately held startup based in Burlington, Mass., said on Friday that its angiography laser scanner, intended to characterize fatty deposits in coronary vessel walls, has been approved by the FDA, according to the New York Times.
So we went ahead to check out the technology behind the device, and here's what we found:
Near-infrared [NIR] diffuse reflectance spectroscopy is a highly developed technique that is in common use in fields such as chemistry and pharmaceutical development to identify the chemical composition of substances. The identification of the chemicals present is based on the differential absorption of light in the NIR spectrum by different molecules. An important feature of near-infrared light is that it can penetrate tissue and can therefore identify a tissue despite the presence of blood between the detector and the target. This is an important advantage for imaging within the human coronary artery.Much of the activity of InfraReDx has been devoted to overcoming the challenges of performing NIR spectroscopy in the human coronary where problems of access, penetration of blood, motion, and the need to scan must be overcome. Fortunately, major advances in lasers and optical devices developed primarily for the telecommunications industry have made it possible to overcome these challenges.
The InfraReDx system consists of a laser light source, an automated pullback and rotation device and a small fiberoptic catheter. While the catheter is similar in size and ease of use to an intravascular ultrasound catheter, the information it provides is quite different since it is based on an optical rather that an ultrasonic signal.
The NIR system obtains signals from patients that are analyzed with algorithms validated by comparison to tissue histologic findings in ex-vivo coronary specimens. It is therefore possible to perform a pullback in a patient’s artery, and provide an image of the NIR signals which indicate the presence of lipid and other chemicals of interest. It is expected that these images, which are called Intravascular Chemograms™, will provide information to interventional cardiologists to help in the care of patients already undergoing cardiac catheterization for a coronary event. It is expected that the initial use of the InfraReDx device will be for diagnosis, which will help in prevention of a second coronary event in the approximately 2 million individuals world-wide who undergo a coronary intervention each year.
The company is also offering the following presentation of its technology:
Product page: InfraReDx Technology...
UPDATE: FDA press release: Coronary Artery Plaque Imaging Device Cleared by FDA...
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Friday, April 25, 2008
VitalJacket: Heart Monitoring Shirt
In an attempt to make heart monitoring less visible and bulky for individuals requiring continuous monitoring of their heart, BioDevices, SA, has a unique solution. The company has developed a T-shirt which continuously monitors heart rate and ECG waves. This is an ideal solution for elderly patients and has a lot of potential for fitness applications as well.
The Vital Jacket® is a wearable vital signs monitoring system that joins textiles with microelectronics. It was designed and developed to be a usable pragmatic approach for different clinical and normal life scenarios, in hospitals, home or on the move, that need continuous or frequent high quality vital signs monitoring from the patient or healthy subject. The concept was designed and specified based on the long tradition on biomedical instrumentation and telemedicine of the IEETA institute of the University of Aveiro, Portugal (www.ieeta.pt/sias).The Vital Jacket® HWM mobile device is an intelligent wearable garnment that is able to continuous monitor electrocardiogram (ECG) wave and Heart Rate for different fitness, high performance sports, security and medical applications.
There are currently two versions, HWM100 that stores data on a SD memory card for posterior analysis in a PC and, HWM200 that allows on-line visualization using a smartphone/PDA.
More from talk2myShirt
More from product page: VitalJacket
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Friday, April 18, 2008
Medtronic Defender Embolic Protection Filter Approved in EU
This device, newly approved for the European market, is designed to get rid of nasty emboli that can occur during a variety of stenting procedures:
Made of braided nitinol (a “memory metal” that resumes its original shape upon deployment), the Defender embolic protection filter has a low profile and a peel-away delivery sheath that enables physicians to maneuver the device easily across lesions to the desired location. When opened, the filter acts as a basket, allowing sufficient blood flow while simultaneously trapping dangerous embolic debris that may become dislodged during the stenting procedure. Without this protection, embolic debris can flow into other portions of blood vessels – and, in the case of patients with carotid artery disease, this can lead to a stroke, one of the world’s leading causes of death and long-term disability...The Defender filter has a 2.2 French (0.029 inch) crossing profile and an extendable 0.014 inch stainless steel core wire that is designed for both flexibility and support. Also, the device’s mesh filter basket design allows the filter to fit snugly against vessel walls, even in eccentrically shaped vessels. This reduces the risk of embolization by preventing particles from migrating through gaps and into the blood stream. Another key feature of the device is its steerability and guidewire-like torque response, which measures the number of revolutions needed to turn the tip 180 degrees within the sheath. Bench testing shows the Defender filter to have improved torque response.
“Torque response is a key attribute for a filter, and Defender performed very well, with a 1-to-1 torque response between the proximal and distal tip of the wire,” said Dr. Dierk Scheinert, director of the Park-Hospital Leipzig and head of the Department of Angiology at the University of Leipzig Heart Center. “We were impressed with the trackability of the system. One of the cases had a long lesion (2 cm) to cross, and the filter went through without any issue.”
Press release: Medtronic Announces CE Mark and European Launch of New 'Defender' Embolic Protection Filter ...
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The Latest on Genetically Created Pacemaker Cells
Back in August 2006 we reported about efforts of scientists to use genetically modified cardiac cells to provide an intrinsic pacemaker function. The idea is to induce some cells to have a stable depolarization frequency by delivering genes that encode for specific sodium and potassium ion channels, which play a critical role in maintaining a normal, regularly paced heartbeat.
The Wall Street Journal Health Blog has an interesting post about the latest in "putting pacemaker genes into the parts of the heart that aren't beating properly," including a video that you can see below that shows genetically engineered pacemaker cells.
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Friday, April 11, 2008
Lumax 540 from BIOTRONIK: AICD with Home Monitoring
BIOTRONIK is reporting that its new Lumax 540 implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) has been implanted in a number of patients in the European Union. The device has been granted CE Mark of approval about two weeks ago. One of the features that BIOTRONIK is particularly proud of is the ability of this device to provide continuous wireless home monitoring for cardiac patients:
The new Lumax 540 platform is part of BIOTRONIK´s most technologically advanced tachycardia product portfolio, providing extended therapy options- for individualized patient device programming as well as BIOTRONIK Home Monitoring® technology for wireless remote monitoring of patient’s cardiovascular status.A comprehensive set of diagnostic capabilities are further technical advancements included on the Lumax 540 devices to help physicians identify clinically relevant atrial fibrillation and early detection of worsening heart failure status.
Due to the advantage of developing its own industry-leading batteries and years of engineering research, BIOTRONIK has achieved longevity for the Lumax 540 platform which extends the life of the devices up to 10 years. “Patients could benefit from this extended battery longevity due to the need for fewer device replacements over time, thereby improving quality of life and at the same time helping to reduce healthcare costs”, commented Marlou Janssen, Vice President Global Marketing and Sales, Cardiac Rhythm Management, BIOTRONIK. “In fact, we are so confident in the advantages of our new battery technology, BIOTRONIK will further extend our warranty for the Lumax 540 ICDs.”
In response to the increasing number of implanted cardiac devices, technologies which ease complex programming, enable remote monitoring and simplify patient follow-up have become increasingly important. Therefore, Lumax 540 series was specifically designed to improve effective tachyarrhythmia programming and facilitate patient follow-up with an innovative set of functionalities that help physicians efficiently automate the in-office follow-up of patients with BIOTRONIK devices.
Furthermore, in combination with BIOTRONIK Home Monitoring® technology, the new Lumax 540 platform sets the standard for remote monitoring of patients with cardiac devices. This exclusive technology enables continuous automatic daily data transmissions of the patient’s cardiovascular status and clinically significant events to the physician from anywhere in the world using an antenna integrated in the Lumax 540 devices and the mobile telephone network...
Lumax 540 devices offer the unique combination of advanced tachycardia therapy management, diagnostic capabilities and remote monitoring technologies which support physicians in creating efficient care pathways for their patients with cardiac devices and further improve patient care.
Press release: BIOTRONIK Announces First Implants of Lumax 540 Series...
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Wednesday, April 9, 2008
Philips HD7
Philips is introducing in the United States its new general purpose, modestly priced ultrasound system, the Philips HD7:
The system provides grayscale and color Doppler imaging with simple one button optimization, as well as Tissue Harmonic Imaging. In addition, the HD7 features a wide array of transducers, an adjustable flat panel LCD monitor, proven system architecture, and advanced imaging, measurement and quantification technologies.The Philips HD7 system addresses basic scanning needs while adding new technology and design advances that help improve image quality. Developed with clinicians in mind, the ergonomic, easy-to-use system can meet the demands for high-volume use in cardiovascular, OB/GYN, anesthesiology, oncology, electrophysiology, stress echo, pediatric, orthopedic, urologic, emergency and other applications.
Like all Philips ultrasound systems, the HD7 has a broadband digital beamformer to capture and preserve more tissue information than conventional narrowband systems and its wide dynamic range and digital focal tuning provide exceptional sensitivity and detail resolution. Features such as iSCAN one button image optimization, multiple transducer ports, DICOM connectivity, and easy data recording to CD or USB, position the HD7 well against other modestly priced ultrasound systems. In addition, optional off-line QLAB quantification software capability allows clinicians to perform post-examination image review and analysis on a PC. Further enhancing the system’s usability is a Study Guide on disk that quickly equips clinicians to use the advanced features of the HD7.
The system can accommodate a range of Philips' transducers for all kinds of clinical applications.
Product page: HD7 Ultrasound System...
Press release: Philips HD7 ultrasound system now commercially available in the United States...
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Monday, April 7, 2008
DRE Medical Introduces World's Smallest ECG System
DRE Inc, a Louisville, KY company, is now distributing its tiny 12 lead ECG system equipped with an interpretation software and other goodies:
The FDA-approved Universal ECG portable PC-based ECG is the most compact and precise PC-based ECG on the market. It connects directly to most desktop PCs, laptops and Pocket PCs running Microsoft® Windows® XP or 2000 and performs resting ECG anytime, anywhere. EKG results are displayed on the computer screen for rapid assessment.DRE distributes the Universal ECG at a price that is less expensive than most standalone EKG machines. The Universal ECG provides additional cost savings upon use: It allows physicians to print EKG reports on standard computer paper, reducing thermal paper costs by as much as $700 per year. The Universal ECG also requires no calibration or annual maintenance and it draws all power from the PC, eliminating battery costs.
The Universal ECG provides automatic measurement analysis and narrative interpretation using the sophisticated Louvaine Algorithm. According to a clinical study, the Louvaine Algorithm has the best total accuracy when compared with algorithms used by leading competitors. The study also found that the Louvaine Algorithm diagnoses Myocardial Infarction more accurately than competing algorithms.
DRE sells the Universal ECG with all components necessary for measuring 12-lead EKG data. It includes:
Intuitive software for collecting, storing and analyzing data on a laptop, desktop PC or Pocket PC Free networking software that lets physicians collect data in more than one location and store results on a single database Software used to move data from one database to another The Universal ECG is available from DRE in a 12-lead interpretive version and a six-lead non-interpretive version.
Press release: DRE Medical Equipment Distributes Compact, Cost-Effective PC-Based ECG
Product page: Universal ECG™ Portable PC-Based 12-Lead ECG
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Monday, March 31, 2008
Sparrow, a Smaller, Gentler Stent Goes on Trial
CardioMind, a Sunnyvale, California startup developing a new coronary stent called Sparrow™, has announced that the device was successfully implanted in a dozen Australian patients as part of an initial clinical trial. The stent was designed to target blood vessels smaller than 2.75 mm in diameter, according to the company.
The unique design of the CardioMind Sparrow stent permits it to travel within the guidewire lumen to the site of the lesion. There the cardiologist releases the stent and allows it to self-expand to the vessel wall. By contrast, conventional balloon-expandable stents travel over guidewires to the lesion, and thus, by their very design, occupy more volume.
The Sparrow stent also offers more flexibility than current stents, making it especially adaptable to treatment of the small, tortuous blood vessels often associated with diabetes.
To coat the Sparrow stent, CardioMind has licensed the rights to the SynBiosys biodegradable polymer system from SurModics, Inc. "The SynBiosys polymer allows the Sparrow stent to gradually return to a bare metal state, where we as an industry have 15 years of data showing no increase in late stent thrombosis," says Maroney.
Press release: CardioMind Launches First-in-Human Trial of Small Vessel, Drug-Eluting Stent...
CardioMind website with nothing inside...
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Debris Aspiration During Heart Attack Improves Cardiac Blood Flow, Chances of Survival
The latest news from the ongoing meeting of the American College of Cardiology in Chicago is that using the Export® Aspiration Catheter from Medtronic before stenting, in patients with ongoing acute myocardial infarction (AMI), can "significantly improve blood flow and survival rates compared to conventional treatment with percutaneous coronary intervention (PCI) alone." The study, led by Felix Zijlstra, MD, PhD from University Medical Center Groningen, Netherlands, recruited 1,071 patients who were randomly assigned to PCI supported by the Export aspiration catheter (535 pts) or to PCI using conventional techniques (536 pts).
From the joint statement by the Society for Cardiovascular Angiography and Interventions and the American College of Cardiology:
To assess the quality of myocardial perfusion, the researchers documented myocardial blush grade. A myocardial blush grade of 0 or 1 indicates that little or no x-ray dye has reached from the surface artery into the heart muscle, a sign that the microcirculation is blocked. A myocardial blush grade of 3 indicates that x-ray dye has reached deep into the heart muscle, a sign of good blood flow through the microcirculation. A myocardial blush grade of 2 falls in between. Analysis of the elevated ST-segment on the electrocardiogram -- specifically, its return to a normal baseline -- was also used to gauge the quality of blood flow to the heart muscle.During angiography, researchers observed a blush grade of 0 or 1 in 17 percent of patients treated with the aid of the aspiration catheter and in 26 percent of patients treated with conventional PCI (p less than 0.001). At 30 days, clinical outcomes were strongly related to the degree of myocardial reperfusion. The rate of death in patients with a myocardial blush grade of 0/1, 2 and 3 was 5.2 percent, 2.9 percent and 1.0 percent, respectively (p equals 0.003). The combined rates of repeat heart attack, repeat procedure in the target artery and death in patients with a myocardial blush grade of 0/1, 2 and 3 were 14.1 percent, 8.8 percent and 4.2 percent, respectively (p less than 0.001).
At one-year follow-up, mortality was significantly lower in patients treated with the aspiration catheter (p equals 0.04), as was a combination of death and heart attack. A similar, highly significant relationship was observed between myocardial blush grade and death, or a combination of death and repeat heart attack (p equals 0.001).
The study team concluded that the degree of blood perfusion into the heart muscle helps to predict the patient's clinical condition, and that aspiration of debris from the treated artery during PCI can reduce the risk of death and repeat heart attack, even one year later.
Device That Clears Debris From Artery Aids Blood Flow in PCI... (.pdf)
Product page: Export® XT Aspiration Catheter...
Medtronic press release: Heart Attack Patients Benefit from Thrombus Aspiration Prior to Stenting, Study Shows...
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Wednesday, March 19, 2008
CardioNet Monitor
CardioNet Inc., a San Diego, CA company, has raised today $81 million with its initial public offering of 4.5 million shares. Despite today's general share drop, we are intrigued by CardioNet's technology, a mobile cardiac telemetry monitor recorder, as well as the service that the company offers. 
CardioNet is particularly proud of the fact that when its CardioNet MCOT monitor was compared to typical LOOP event monitors in a study (J Cardiovasc Electrophysiol, Vol. 18, pp. 1-7, March 2007 (.pdf)), it was found to be 3 times superior at detecting clinically significant arrhythmias.
More about the product:
Once enrolled with CardioNet, physicians prescribe CardioNet for patients for up to 21 days of monitoring. CardioNet monitors patients 24 hours a day via the small sensor and monitor the patient wears as they continue with their normal daily routine. As events occur, patient activity is automatically transmitted to the CardioNet Monitoring Center for analysis and response.The CardioNet Monitoring Center provides physicians with the succinct, integrated information they need for diagnosis and therapy management. The physician selects the events to be monitored, and the level and timing of response by the CardioNet Center – from routine daily reporting to stat reports. Physicians can receive the data via fax or the Internet. Reports have been designed to allow rapid review of results, graphing related data and trends.
CardioNet provides an inservice specialist who assists the physician’s staff in enrolling patients, and a patient educator who instructs patients on the setup and use of the CardioNet System.
The CardioNet staff verifies all information, and quickly enrolls each patient, provides monitoring equipment and education, and begins the monitoring process. CardioNet’s monitoring center reviews all patient event information and creates reports on a daily basis. Physician offices receive daily reports via Internet or fax at the location of their choice. When urgent or emergent events occur and are confirmed by the monitoring technicians, reports are immediately sent to the physician for review. At the end of monitoring, each practice receives an End of Service summary report.
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Stentys, Maker of Bifurcated Self-Expanding Coronary Stents, Gets Financed
Stentys, a Paris, France-based developer of bifurcated cardiac stents, has completed an $18 million 'Series B' round of venture financing led by a UK venture firm Scottish Equity Partners. The company hopes that its "world's first next-generation dedicated stent" for treatment of blocked coronary artery bifurcations will become a standard therapeutic option in cath labs across the world.
More about the technology:
A coronary stenosis can be treated fairly efficaciously with a stent, a small metal spring-like tube that opens up the artery.However treatment of artery bifurcations, which represent one coronary intervention in five, is ineffective : one patient in four suffers from restenosis (recurrence of the narrowing) and must undergo a second intervention, too often a by-pass surgery.
The Stentys stent is as simple to use as a conventional stent and is designed to offer superior clinical results thanks to a full opening and excellent scaffolding of the side branch.
The Stentys provisional strategy (treating the main vessel without compromising the side branch) is a prudent approach, in line with the consensus on bifurcations. If the side branch requires stenting, a standard DES can be placed without excessive gap or overlap.
Stentys stent is covered by a highly haemocompatible polymer used in dialysis devices, and a drug with a proven efficacy against restenosis.
The self expanding properties of the platform ensures complete strut coverage after a few weeks.
Stentys - Easy Bifurcation Stenting...
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Monday, March 17, 2008
Impella Percutaneous VAD to be Studied for Acute MI Patients
The FDA today gave approval to Abiomed to proceed with a clinical study of the Impella® 2.5 Circulatory Support System for patients with acute myocardial infarction (AMI). (2.5 refers to the ability of the device to augment the cardiac output by 2.5 liters per minute.) We've been following Impella, a ventricular assist device designed for percutaneous placement in the catheterization lab, for at least four years now, ever since it was designed and manufactured by Impella CardioSystems AG of Germany.
From today's announcement:
The AMI shock study will determine the safety and effectiveness of the Impella 2.5 as a left ventricular assist device for heart attack patients as compared to optimal medical management with an Intra-Aortic Balloon Pump (IABP). According to a recent American Heart Association report, approximately 865,000 AMI patients are treated annually in the U.S. The study is approved under category B2 status and the trial sites are eligible for full reimbursement from the Centers for Medicare and Medicaid Services (CMS).The randomized study, at up to 150 hospitals, is comprised of two arms; those patients that receive the Impella 2.5 for up to five days as a left ventricular assist device (VAD) and patients that receive IABP therapy. The study will compare 192 Impella 2.5 patients to 192 IABP patients relative to a composite end point comparing safety and efficacy. The primary endpoint will be a composite endpoint of major events assessed at 30 days post-PCI. These major events include but are not limited to: death, acute renal failure, and need for a major cardiovascular operation. The secondary endpoint will be a composite of cardiac function such as ejection fraction, requirement for inotropic support and cardiac power output. Following Institutional Review Board (IRB) approval at each participating hospital and requisite training, the Company plans to ship Impella 2.5 disposables and Impella consoles to enrolled sites.
Check out the product brochure below:
Press release: Abiomed Receives Conditional FDA Approval for Impella 2.5 Study for Acute Myocardial Infarction (AMI) Patients...
Product page: Impella 2.5...
Flashbacks: impella® recover LV ; Impella Recover Devices Approved in Germany for Reimbursement
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Microporous Hydroxyapatite Coating for Drug-eluting Stents
MIV Therapeutics, Inc., an Atlanta, GA company, is a recipient of this year's Frost & Sullivan North America Award For Technology Innovation. The company has developed an innovative hydroxyapatite coating that might be rather useful for the next generation of cardiac stents, and, possibly, other implantable medical devices. Hydroxyapatite is a natural mineral occurring in bone and tooth enamel.
The following is a statement from Frost & Sullivan, followed by some info about the company's technology:
“MIV Therapeutics has innovatively leveraged a polymer-free approach to tackle the present day limitations of first- and second-generation stents to develop a product characterized by excellent biocompatibility, flexibility, and optimal drug delivery,” notes Pramodh Ishwarakrishnan, the Frost & Sullivan analyst who nominated MIV Therapeutics for the award...At the present time the Company is aggressively pursuing the commercialization of three unique leading edge proprietary technologies:
NanoFilm Hydroxyapatite surface modification or coating
MicroPorous Hydroxyapatitesurface modification or coating
Polymer-free lipid-based drug eluting and encapsulation formulations HAp is naturally found in bone and tooth enamel. Numerous results from clinical tests and surgical practice have shown that in addition to its demonstrated biocompatibility, this new generation of advanced biocompatible coatings is non-toxic and does not trigger adverse reactions of the human immune system. Extensive animal studies performed by MIVT also confirmed that Hydroxyapatite, when applied to vascular applications, does not induce thrombogenicity, allergic or inflammatory reactions commonly associated with polymeric coatings, therefore making it a solid candidate as a potential coating for coronary and peripheral stents, and other implantable medical devices.
MIVT’s HAp coating technology has demonstrated that it can meet the stringent technical requirements set by the regulatory agencies for coatings of cardiovascular stents. MIVT coating technologies completed successfully a comprehensive range of demanding animal and mechanical trials required for CE Mark and FDA approvals in both Europe and the US. These include thrombogenicity (blood clotting), cytotoxicity, and 400-million-cycle fatigue life testing. The results of these extensive tests confirmed exceptional biocompatibility and safety of these coatings and paved the way for human trials.
On May 31, 2007, MIVT announced the first ever human implantation of a hydroxyapatite coated stent and the launch of the MIVT Pilot Trial which will evaluate the safety and efficacy of the VESTASYNC, MIVT’s polymer-free nanoscale microporous hydroxyapatite drug-eluting stent for the treatment of single de novo lesions in native coronary arteries.
Press release: MIV Therapeutics Receives 2008 Frost & Sullivan North America Award For Technology Innovation...
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Wednesday, March 12, 2008
ThermoSuit Studied as an Adjunct Treatment for MI
ThermoSuit, a hypothermia water immersion system from Life Recovery Systems, HD, LLC, of Alexandria, LA, is now being tested in a study to determine the device's ability to reduce post reperfusion infarct size in patients with acute MI, who are undergoing revascularization by angioplasty. We have originally covered the device back in September 2007.
From the press release:
Life Recovery Systems, HD, LLC announced today approval by the Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) application to investigate rapid hypothermia treatment in combination with primary angioplasty to treat heart attacks.Previous clinical data suggested early and rapid cooling before reperfusion therapy with primary angioplasty may potentially reduce infarct size post reperfusion. The study will enroll up to twenty patients at two institutions who present within six hours of symptom onset and require PCI to restore blood flow to the heart. Patients will receive hypothermia with the Life Recovery Systems ThermoSuit(R) non-invasive cooling system. Cooling will be performed in the emergency room within 60 minutes of arrival and cooling time is to be less than 30 minutes to avoid prolonging door-to-balloon time beyond 90 minutes.
The study is co-chaired by Dr. Paul McMullan and Dr. Christopher White, Chairman of Cardiology for Ochsner Health System in New Orleans, LA.
In the Cool MI I trial a subset of patients with anterior infarctions and whose temperature at the time of reperfusion was below 35 degrees C (26% of all anterior MI's in the cooled group) had a significantly smaller infarction (9.3% of the left ventricular mass in the cooled population vs. 18.2% in the control group p=0.05) than the control group, said Dr. Paul McMullan.
The goal of this pilot study is to confirm the feasibility and efficacy of external thin film liquid cooling to achieve "target" temperature within 30 minutes or less, and to demonstrate ease of maintenance of target temperature for three hours following removal of the patient from ThermoSuit(R). Primary safety endpoints data will also be collected. If this trial successfully achieves it its endpoints, a larger prospective randomized trial will be conducted.
Sounds honky dory? Not really. At least not yet. Hypothermia has its own bunch of issues: coagulopathy, arrythmogenic potential, and many more. So we'll wait and see what the study shows.
Press release: Life Recovery Systems Study of Heart Attack With ThermoSuit(R) System...
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Tuesday, March 11, 2008
REPLY, World's Smallest Pacemaker OK'ed in Europe
The world's smallest dual chamber pacemaker from Italian firm The Sorin Group has received EU's CE Mark of approval, and now has been implanted in the first patient, according to the company. The 8cc device sports the company's proprietary pacing mode, SafeR™:
Delivering unnecessary pacing to the right ventricle has been shown to significantly enhance the risk of patients developing heart failure and atrial fibrillation, two conditions that can prove fatal and place a heavy cost burden on healthcare systems.While conventional pacemakers deliver unnecessary ventricular pacing in patients without heart block 50 to 80 percent of the time, SafeR™ reduces pacing in the ventricle to less than 0.1 percent in the same patients. Heart block is an electrical conduction disorder that results in the inability of the atria and ventricles, the heart's chambers, to beat in a synchronized way.
In addition to SafeR™, the REPLY™ pacemakers bring together advanced, automatic features that provide easier patient management by simplifying device checks.
The first REPLY™ pacemaker implants were successfully performed by Dr. Georg Noelker, M.D., in the Internal Medicine Department headed by Professor Johannes Brachman, M.D., Klinikum Coburg, Germany and by Dr. Ezio Aimé, M.D., at the IRCCS Policlinico of S. Donato, Milan.
Professor Brachman commented: "I've been using the first generation of SafeR™ since its introduction in 2003. This exclusive pacing technology has brought tremendous benefits to my patients who are now given chances to rely on their heart's natural conduction when it is intact. I really appreciate SafeR™ because it
provides optimal pacing therapy to my patients." The SafeR™ technology builds on the Sorin Group's proven AAIsafeR™ mode, the first pacing mode designed to limit unnecessary ventricular pacing that was available in a pacemaker. AAIsafeR™ was first launched in September 2003 in Europe and received FDA approval in May 2005. Sorin Group was the first company to receive U.S. market clearance for a pacemaker incorporating a pacing mode that minimizes ventricular pacing.
Product page: REPLY...
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Monday, March 10, 2008
Edwards Sapien Transcatheter Aortic Valve Makes Human Debut
Edwards Lifesciences is reporting that the first three human implants of the next-generation Edwards transcatheter aortic heart valve, dubbed Edwards Sapien THV, were performed by John Webb, M.D., director of the cath lab and cardiac intervention at St. Paul's Hospital in Vancouver, BC. This percutaneous valve, conceived for the treatment of severe aortic stenosis, could be delivered via transfemoral approach (with the RetroFlex delivery system) or via transapical placement (with the Ascendra delivery system). The picture below illustrates the transapical approach.
Edwards' next-generation balloon-expandable pericardial tissue valve features a cobalt chromium alloy frame that reduces the profile by four to five French. This enables easier access into and within the patient's vasculature for delivery of the valve without open-heart surgery. The new valve will also be offered in additional sizes and builds upon Edwards' more than 20 years of clinical experience and innovation with the most advanced tissue engineering technologies.
"This is a very exciting milestone in the progression of minimally-invasive valve therapy. The refinements to the new Edwards valve provide the opportunity to make the transcatheter technology available to an even broader group of patients suffering from severe aortic stenosis," said Webb, who along with his multidisciplinary team has performed more than 150 transcatheter aortic valve replacement procedures. "Providing patients and clinicians with a comprehensive selection of treatment options, including this new valve, can increase the likelihood that these very ill patients will seek and find appropriate treatment."
Edwards is the only company currently engaged in a U.S. clinical trial of a transcatheter aortic heart valve. The Edwards SAPIEN valve with both the RetroFlex transfemoral and Ascendra transapical delivery systems is being evaluated in the PARTNER (Placement of AoRTic traNscathetER valves) pivotal trial for U.S. Food and Drug Administration (FDA) approval.
"We estimate that for every patient who receives an aortic valve replacement, there is another who goes untreated; half of these untreated patients with severe symptoms will die within two years," said Craig Smith, M.D., chief of the division of cardiothoracic surgery at New York-Presbyterian Hospital/Columbia University Medical Center and the co-principal investigator for the U.S. PARTNER trial. "Soon physicians will be able to treat virtually all high-risk aortic stenosis patients with transcatheter valves, delivered transapically or transfemorally, as we continue to carefully study the long-term performance of this technology."
Product page: Edwards SAPIEN Transcatheter Heart Valve...
Press release: Edwards Lifesciences Announces First Human Implants of Next-Generation Transcatheter Heart Valve...
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Friday, March 7, 2008
FloWave 1000 Monitor Promises Noninvasive Cardiac Output
One EKG lead. One pulse oximeter. Some secret stuff. And presto! Profit... and, of course, noninvasive cardiac output monitoring. Woolsthorpe Technologies, a Brentwood, Tenn. company, 
is reporting that its hemodynamics device FloWave 1000 is now being evaluated in clinical trials in Vanderbilt University Medical Center and in Saint Thomas Research Institute in Nashville, and in the Texas Heart Institute in Houston. The device, based on a single paired ECG lead, dual pulse oximetry sensor, and a secret proprietary algorithm, is designed to extrapolate patient's cardiac output, cardiac index, stroke volume, heart rate, saturation, and more.
The device has been around for at least 4 years now, as this article from 2004 in Nashville Business Journal testifies. But since the company is putting out perky press releases, and The Tennessean reports about the company as the greatest thing since the sliced bread, our pulse and cardiac output go up slightly. Let us hope there is enough blood flow in the company to deliver on its promises.