Those who suffer from stroke and ultimately those with head trauma, brain injury or in cardiac arrest may in the not-too-distant future have another weapon in the physician arsenal to fight brain swelling, the result of disease or injury that often causes more damage than the original trauma. CoolSystems (Berkeley, California) last month reported its partnership with the Stanford Stroke Center at the Stanford University Medical Center (Palo Alto, California) to study its device for cooling the brains of individuals who have suffered stroke and other head injuries. The device is essentially a soft-fabric hood, with a liner through which flows ice water, powered by an accompanying mobile unit, to slow or retard stroke-induced swelling. At the same time the liquid flowing through the helmet-like device cools the body, but at a much slower rate to create a differential in temperature, according to CoolSystems.
The device is essentially a new form of external cooling, and an alternative to the internal cooling systems currently being developed by some companies. But Tom Oliver, CoolSystems' chief executive officer, says those internal systems have obvious drawbacks. "If [doctors are] trying to put the cold salt water in the veins or cooling the blood through a blood cooler, that is all very high risk, and people just don't want to do it," Oliver told Cardiovascular Device Update. "The other thing is, if you ice the body [you can have] trouble with your internal organs." Icing the body can result in over-cooling and "other adverse effects," he said.
The company, whose technology was inspired by work at the National Aeronautics and Space Administration (Houston, Texas), said that the results of a study of an earlier prototype conducted at the University of Illinois at Peoria funded by CoolSystems were reported in early February at the American Heart Association's (AHA; Dallas, Texas) 29th International Stroke Conference in San Diego, California, and in the February issue of the Journal of Neurosurgery. Oliver characterized the publication of highly positive results from the University of Illinois study as "great," but he noted that its system has been upgraded to work even more efficiently since then. "That was a very early pilot study for research and the great news is, it did work," Oliver said. "We've actually, over the last year or two, really improved the head liner itself."
And this is not the company's first or only effort in the development of cooling devices. CoolSystems was founded in 1997-98 and funded by investors in late 1999 before Oliver came on board in May 2000. Its first interest was in the development of a cooling vest and an attached hood for patients with multiple sclerosis (MS). These patients highly heat-sensitive frequently become overheated beyond their normal core temperature, worsening their symptoms, such as fatigue. Although CoolSystems has sold the Recharge Active Cooling System "to individuals across the country," the company is just now getting to the stage of full market launch, Oliver said.
As compared to the early-stage development of the cooling helmet and the ready-to-launch vest, the company has already moved ahead to develop a device for athletes to cool and compress muscles to treat sports injuries. Today, some of CoolSystems' investors are athletes "with household names," he said. The product for athletic injuries is called the Game Ready Accelerated Recovery System, a system that uses ergonomic wraps and an adjustable control unit to simultaneously provide cold therapy and intermittent compression.
For the stroke patient cooling device, the path will be longer, since the company will have to win FDA approval, Oliver noted. Toward that end, CoolSystems expects that the studies now under way at Stanford will provide the necessary clinical trial data needed for an application to the agency. The Phase I study at Stanford, which includes 20 patients, involves not only stroke patients but also individuals with head injuries. "They actually have these probes [that] measure a lot of the things going on in the brain, as well as temperature," Oliver said. "That's where we'll get more scientific data." A Phase II study will involve 80 stroke patients, and CoolSystems said it expects that the trial will take place at several sites, although he could not reveal the names of additional institutions until plans are finalized.
And what are Oliver's greatest hopes for the product's potential? "What would be wonderful for myself and everybody in the company has a passion for this and helping people is if this was a standard of care for head trauma, concussion, stroke," he said. "And if it helps speed the recovery [from] cardiac arrest, that would be beyond everybody's dreams."
Elsewhere in the product pipeline:
AngioDynamics (Queensbury, New York), a wholly owned subsidiary of E-Z-EM (Lake Success, New York), reported FDA clearance for its SpeedLyser infusion catheter the first infusion catheter designed for dissolving thrombus from a blocked dialysis access site. The SpeedLyser infusion catheter has pressure responsive orifices, which help evenly distribute the thrombolytic agent to the blockage. The product also features a coaxial system, consisting of a 3Fr inner and a 5Fr outer catheter, which provides a combination of fast access and even drug delivery across the entire thrombosed graft. The company said it expects to begin marketing the product to the dialysis market in the first quarter of 2004.
Biosite (San Diego, California) said it has received clearance from the FDA to market the Triage BNP Test for Beckman Coulter Immunoassay Systems, a diagnostic test that measures B-type natriuretic peptide (BNP). The Triage BNP Test for Beckman Coulter Immunoassay Systems, recently launched in Europe, is now available to customers in the U.S. through Biosite's direct sales force and Fisher Healthcare (Hampton, New Hampshire). Beckman Coulter (Fullerton, California) will manufacture the test for Biosite, and Biosite will exclusively sell and market the product. Designed to provide results standardized to match Biosite's existing rapid, portable Triage BNP Test, the newest BNP test has received FDA clearances for use in the diagnosis of congestive heart failure, assessment of disease severity and for the risk stratification of patients with acute coronary syndromes, all of which apply regardless of the system on which the test is performed.
Biotronik (Lake Oswego, Oregon) said the FDA has approved interactive Internet access to the Biotronik Home Monitoring early detection system. Available for both implantable cardiac defibrillators and pacemakers, it is the first early detection system for cardiac implant devices, according to the company, and is available for both implantable cardiac defibrillators and pacemakers. The system delivers automated, wireless early detection of events for cardiac rhythm management (CRM) from implantable devices linked directly to the Internet, enabling the reporting of critical CRM event information for early intervention. With the newly approved Home Monitoring Website, physicians have greater control over many aspects of the early detection reporting and data management process.
Boston Scientific (Natick, Massachusetts) said it has received the CE mark for its new coronary stent, the Liberte. The company said it plans to launch the stent immediately in Europe and other international markets, and in the U.S. in the second half of 2004. Boston Scientific said the Liberte stent will serve as the platform for its next generation drug-eluting stent system. It said it plans to file an investigational device exemption with the FDA for clinical trials of its drug-eluting stent system in the first half of 2004. "The Liberte represents a major advance in stent development," said Paul LaViolette, Boston Scientific senior vice president and group president, cardiovascular. "It is a sophisticated technology designed to greatly enhance deliverability and conformability, particularly in challenging lesions. The deliverability enhancements improve access, while the conformability enhancements allow the stent to better follow the natural contours of the vessel." Separately, Boston Scientific reported the start of enrollment in the ARRIVE registry program, which plans to enroll 2,000 patients at about 50 centers in the U.S. It is designed to collect and analyze "real-world" safety and clinical outcomes data for the Taxus Express2 paclitaxel-eluting stent system in the treatment of patients with coronary artery disease. In cooperation with the FDA, the ARRIVE registry has been initiated prior to FDA approval of the Taxus system, and will continue post-approval. Boston Scientific also reported that it has completed enrollment of a clinical trial to evaluate the benefits of stenting in conjunction with embolic protection to treat carotid artery disease. The clinical trial is using the company's FilterWire EZ Embolic Protection System and Carotid Wallstent Monorail Endoprosthesis to treat patients who are at high risk for the surgical treatment of carotid endarterectomy. The single-arm clinical trial, known as BEACH, is a prospective, non- randomized trial enrolling 747 patients at 47 sites across the U.S. There are 480 patients studied in the pivotal phase of the trial.
CardioDynamics (San Diego, California), the developer of Impedance Cardiography (ICG) technology, reported the publication of an ICG hypertension study in the February issue of Congestive Heart Failure showing a 57% blood pressure control rate in previously uncontrolled hypertensive patients in a generalist physician setting. Researchers at Harrison Memorial Hospital (Bremerton, Washington) treated resistant hypertensive patients on two anti-hypertensive medications using the company's BioZ and Mayo Clinic (Rochester, Minnesota) hypertension algorithm. Over a three-month period, 57% of the previously uncontrolled patients achieved blood pressure under 140/90 with the aid of ICG-guided therapy. The study's investigators concluded that their results "demonstrate superior blood pressure control using a treatment algorithm and serial hemodynamic measurements compared with clinical judgment alone in a randomized prospective study." In subjects with uncontrolled blood pressure on two antihypertensive agents, they said "ICG-guided pharmacologic decision-making resulted in a significant reduction in blood pressure and improvement in blood pressure control. ICG is a safe, effective, and cost-effective tool to assist community generalists treating uncontrolled hypertension."
CardioGenesis (Foothill Ranch, California) said that "conclusive new data" on the long-term benefits of angina-relieving transmyocardial revascularization (TMR), when performed in conjunction with coronary artery bypass grafting (CABG) surgery compared to patients undergoing CABG alone, was presented at the Society of Thoracic Surgeons (STS; Chicago, Illinois) meeting in San Antonio, Texas, in late January. The five-year data is a follow-up to the prospective, randomized, multi-center trial data originally published in 2000 in The Journal of Thoracic and Cardiovascular Surgery. That data, compiled a year after the surgeries, showed TMR plus CABG provided significantly reduced 30-day mortality when compared to CABG alone (1.5% vs. 7.6%). CardioGenesis also said that a new minimally-invasive, robotically-assisted approach to TMR was highlighted at the STS meeting.
Chase Medical (Richardson, Texas) said results of a study on heart failure patients who received its TRISVR (tri-saver) surgery were presented at the Society of Thoracic Surgeons meeting in San Antonio, Texas. The TRISVR procedure, a surgical alternative to treat heart failure, uses the Mannequin Endoventricular Shaping Device to resize and reshape the damaged heart very close to its original form, helping the weak heart to pump more efficiently. The study, which includes 175 patients, showed an 89% survival rate in those who have been followed over a 19-month period. The study results showed the TRISVR procedure helped to significantly improve the overall pumping function of the damaged heart; improve the level of heart failure classification; and improve the heart valve function, resulting in lengthened life for patients, the company said.
CHF Solutions (Brooklyn Park, Minnesota) reported that the Minnesota Heart Failure Consortium (MHFC; Minneapolis, Minnesota), a non-profit research organization, has launched a clinical study of the company's System 100 Fluid Removal System, a mechanical pump/ultrafiltration system that removes excess fluid from fluid-overloaded patients. Called RAPID CHF (Randomized Control Trial of Ultrafiltration for Decompensated Congestive Heart Failure), the study is designed to demonstrate the efficacy of ultrafiltration vs. the best medical therapy drugs in hospitalized congestive heart failure patients with fluid overload. The RAPID CHF study is assessing several measures of clinical efficacy, including total weight loss, quality of life, level of CHF disease classification, length of hospital stay and blood chemistry changes before, during and 30 days after treatment. The RAPID CHF study is under way at six Minneapolis/St. Paul-based hospitals and will enroll 40 patients.
CryoCath Technologies (Montreal, Quebec) said that multiple abstracts and a symposium pertaining to the ablation of atrial fibrillation (AF) using the company's SurgiFrost CryoSurgical Ablation System were presented at the fourth annual Surgical Treatment of AF Conference in late January in San Antonio, Texas. Robert Hebeler, MD, of Baylor University Medical Center, reported that 32 out of 33 patients remained free of AF symptoms 5.8 months after treatment with SurgiFrost, a 97% success rate. An abstract from James Gammie, MD, of the University of Maryland, reported an average 8.2-month follow-up success rate of 95%, based on 20 patients. During a dedicated symposium on cryosurgery for the treatment of AF, Charles Mack, MD, of New York Presbyterian Hospital, reported a nearly 90% success rate with 30 patients at six-month follow-up at his center. No adverse events were reported at any of the centers. The SurgiFrost system uses a single-use surgical cryoprobe to treat cardiac arrhythmias while a patient is undergoing a primary cardiac surgical procedure such as coronary artery bypass grafting or mitral valve replacement or repair.
Dade Behring (Deerfield, Illinois) said it has received clearance from the FDA for use of its N High Sensitivity CRP assay as an independent risk marker for the identification of individuals at risk for future cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, N High Sensitivity CRP measurements may also be useful as an independent marker of prognosis of recurrent events in patients with stable coronary disease or acute coronary syndromes. Studies have shown that measurement of CRP by high sensitivity assays is a strong independent predictor of risk for future cardiovascular and peripheral vascular disease. The N High Sensitivity CRP assay, which may be run on Dade Behring BN instrument systems, is the first high-sensitivity CRP assay to receive FDA clearance with a cardiac-specific claim.
Digirad (San Diego, California) reported the release of its OptiCount collimator, which increases the organ sensitivity of Digirad's nuclear cardiology imaging systems by an average of 15% per detector head, while maintaining the same level of reconstructed image spatial resolution. When used in conjunction with Digirad's third-generation Solidium detectors, OptiCount collimation improves organ sensitivity by at least 30% over specifications listed for some conventional competitive Anger cameras. The OptiCount product is available as an optional accessory on new solid-state gamma cameras or as an upgrade to Digirad's existing installed base of cameras.
Edwards Lifesciences (Irvine, California) reported the launch of two new heart valve products in the U.S. at the 40th annual scientific meeting of the Society of Thoracic Surgeons in San Antonio, Texas. The Perimount Magna valve was recently approved by the FDA and is described by the company as "the first and only device of its kind that combines more than 20 years of clinical experience and innovation with the most advanced tissue engineering technologies, including Edwards' proprietary XenoLogiX tissue treatment that removes calcium-binding phospholipids from the valve's tissue leaflets." The company also launched its new Carpentier-McCarthy-Adams IMR-ETLOGIX annuloplasty ring, designed for ischemic mitral heart valve repair, created to address the asymmetrical deformities and poor leaflet closure caused by myocardial infarction and coronary artery disease. The IMR-ETLOGIX ring is designed to reconfigure the valve's annulus to reduce mitral regurgitation. Edwards also has received FDA approval for its ThermaFix process, an advanced tissue treatment developed to mitigate calcification of tissue heart valve leaflets. The ThermaFix process was co-developed with Edwards by Prof. Alain Carpentier, chairman of the department of cardiovascular surgery at the Hopital Europeen Georges Pompidou (Paris) and inventor of Edwards' line of Perimount tissue replacement heart valves. The ThermaFix process will be featured initially on select Edwards heart valves, including the Carpentier-Edwards Perimount Magna valve.
Endologix (Irvine, California) has received U.S. patent No. 6,660,030 B2, "Bifurcation Graft Deployment Catheter," and No. 6,663,665 B2, "Single Puncture Bifurcation Graft Deployment System." These devices are used to deploy Endologix's endoluminal stent graft (ELG) during minimally invasive treatment for abdominal aortic aneurysms (AAA). These newly issued patents expand Endologix's AAA patent portfolio to 13 U.S. patents issued, with 269 claims. The company said it expects to file a full pre-market approval submission for the PowerLink System with the FDA by year-end and anticipates receiving marketing approval during the second half of 2004.
GenVec (Gaithersburg, Maryland) reported the issuance of U.S. patent No. 6,673,604, titled "Muscle Cells and Their Use in Cardiac Repair," which covers transplantable skeletal myoblast compositions (muscle cells) that can be used to treat any cardiac condition. The patent coverage is not limited to cardiac disease, and can be applied to other medical conditions that could be improved through muscle cell transplantation.
Guidant (Indianapolis, Indiana) has launched its Acrobat SUV (Swivel, Universal, Vacuum) Stabilizer System for beating-heart surgery. The Acrobat SUV Stabilizer System is the next-generation addition to the established Acrobat line of stabilization devices. The system is designed to provide optimal stabilization and visibility during coronary artery bypass graft (CABG) surgeries. "Currently, beating-heart surgery accounts for 25% of all CABG procedures performed in the U.S.," said Maria Degois-Sainz, president of Guidant's Cardiac Surgery business. "With the introduction of Acrobat SUV, Guidant will strengthen its competitiveness in this important market." Beating-heart stabilization devices such as the Acrobat SUV provide surgeons with the ability to perform CABG while the heart is still beating, eliminating the need for a heart-lung machine. The system includes the Acrobat Stabilizer and the Xpose Access Device, which is designed to lift the heart, allowing the surgeon to position and access blood vessels.
Medtronic (Minneapolis, Minnesota) reported FDA clearance and U.S. commercial release of the Medtronic EnPulse pacing system. The new system incorporates an enhanced suite of features to help physicians better manage patients with slow heart rhythms, the company said, including Search AV+, an automatic and expanded search method that senses the patient's natural heartbeats before delivering pacing therapy; Quick Look II screen, which allows clinicians to instantly access complete information about the patient's heart rhythm and pacemaker activity on a single, easy-to-understand screen; and Ventricular Response Pacing. The dual-chamber devices can be upgraded with new therapies, allowing for forthcoming enhancements that in the future could be enabled without patient surgery through a programmer software upgrade. Separately, Medtronic said it has begun the distribution of the Medtronic Paceart System 2004 First Edition to help clinics that specialize in heart rhythm disorders improve the electronic organization of cardiac device and patient heart rate data. The new release expands the accessibility of data managed within Paceart by providing an electronic interface between the Paceart system and an array of healthcare information systems. The new export module uses XML and PDF standards for data transmission and formatting, which enables broad compatibility with and access from other systems. Medtronic also reported the market release of two new Attain left-heart delivery systems, both designed to facilitate placement of left-heart leads during implantation of CRT devices. The Attain Prevail system is the first left-heart lead delivery system to combine steerability, catheter telescoping and vein subselection in a single package. It allows the user to create multiple curve shapes without changing guide catheters, and also permits deep advancement of the guide catheter and guide wire. Its soft, tapered tip design and small size helps minimize the chance of venous trauma. The Attain Deflectable guiding catheter provides physicians with an opportunity for successful coronary sinus cannulation and left-heart lead placement. Implanters are able to vary the catheter curve to match a patient's anatomy and, once cannulation has been achieved, the Attain Deflectable provides a stable workstation for the passing of guidewires, leads and venogram balloon catheters for greater visualization of the cardiac venous anatomy. Both new delivery systems allow contrast injection through the lumen to help visualize the anatomy, especially the cardiac veins on the left ventricle. The Attain Prevail can be inserted into fixed shape catheters to accomplish telescoping techniques, and the Attain Deflectable allows for adjustable curve reach and telescoping with a guide wire and over-the-wire lead. Additionally, Medtronic reported the first implant of the Sprint Fidelis defibrillation lead family. At 6.6 Fr in body diameter, Medtronic said the lead is the smallest in the industry and is used with implantable cardioverter defibrillators. The lead's small body is designed to minimize venous obstruction and reduce tissue growth around the defibrillation coils.
MicroMed Technology (Houston, Texas) reported FDA approval of the company's request to supplement its IDE-approved destination therapy clinical trial. The supplement changes the patient randomization scheme to a 2:1 ratio of MicroMed DeBakey VAD implants to Thoratec (Pleasanton, California) HeartMate XVE implants. Up to 360 patients will participate in the study, with an interim patient review available once 152 patients have received the implants. In the randomized trial, Destination Evaluation Long- Term Assist, two of every three patients participating will be implanted with the DeBakey VAD. MicroMed has reviewed this ratio of VAD usage with its 30 clinical trial sites and said it believes this format will allow for a more rapid demonstration of the DeBakey VAD's value in comparison to traditional devices. MicroMed reports the implant of DeBakey VADs in more than 230 patients worldwide. It also is conducting a bridge to transplant pivotal trial in the U.S.
SS&II (Manchester, New Hampshire) reported the allowance of all claims of U.S. patent publication No. 20020151924, covering an angioplasty balloon with ridges mounted on its outer surface for treating occluded coronary and peripheral arteries. The balloon also incorporates a folding mechanism that shields the ridges and protects the arterial wall during delivery and withdrawal of the catheter. The ridges concentrate the balloon's dilating force and enable the opening of resistant lesions. This new design minimizes balloon stiffness, preserves the maneuverability of the device as it negotiates curved vessels, and reduces several risks, drawbacks and length limitations associated with the use of metal ridges in presently marketed devices, the company said.
Tepha (Cambridge, Massachusetts) reported what it called "a major step forward" in the development of absorbable elastomeric biomaterials for use in cardiovascular stents and other medical devices. The company submitted a device master file to the FDA in December for its TephELAST biomaterial, a biologically produced absorbable elastomer. The thermoplastic polymer can be processed via conventional melt and solvent processing techniques into virtually any shape or form.
Welch Allyn (Skaneateles Falls, New York) introduced two new multi-channel electrocardiographs (ECG), the Welch Allyn CP 10 and CP 20. Both units are battery-operated and feature alphanumeric keyboards for easy entry of patient demographics, full-size user programmable reports that print on thermal paper, and advanced filters for optimal ECG trace quality. The more sophisticated CP 20 offers the option of connecting with many electronic medical record systems through the Welch Allyn CardioPerfect Workstation software. The Welch Allyn CP 10 offers non-interpretive 12 lead resting ECG with ECG measurements standard and an LCD screen for easy patient data entry. The Welch Allyn CP 20 boasts the same easy-to-use operation and functionality as the CP 10, but also features an eight-channel ECG preview screen, and storage and transmission capability for up to 50 ECGs.
WorldHeart (Oakland, California) reported that the FDA has approved its premarket approval supplement submission to incorporate several engineering enhancements to the implanted and external components of its Novacor left ventricular assist system (LVAS). Improvements that will benefit recipients include: quieter pump operation; new battery packs that are 40% lighter and operate for 40% longer; and a smaller and quieter battery charger. The implantable components of the system carry a three-year warranty, which remains unchanged. The company said introduction of the enhancements in the U.S. and Canadian markets will begin following completion of the final labeling and production of the modified systems. WorldHeart also reported that a heart-failure patient in Germany became the 1,500th recipient of a Novacor LVAS. O.A. Dr. Latif Arusoglu, of the department for Thorax and Heart Surgery at the Heart and Diabetes Center (Bad Oeynhausen, Germany), carried out the implant.
Xtrak Medical (Salem, New Hampshire) reported FDA clearance for its TOPS support catheter. The TOPS operates over standard .014" to .018" steerable guidewires to assist crossing difficult occlusions. Once the occlusion is crossed, TOPS is withdrawn while maintaining guidewire position and an angioplasty balloon is delivered through the pilot lumen that was formed across the occlusion. Since TOPS operates over standard guidewires, in either fully over-the-wire or rapid exchange versions, it can be easily incorporated into an ongoing procedure at any time without needing an exchange-length guidewire.
Zoll Medical (Chelmsford, Massachusetts) said that study results show its Rectilinear Biphasic waveform (RBW) improves the resuscitation of out-of-hospital cardiac arrest patients. The results were presented at the National Association of EMS Physicians Conference (Lenexa, Kansas) in Tucson, Arizona. The study was a retrospective analysis covering two years of pre-hospital cardiac arrest data with a total of 294 patients. The Zoll RBW defibrillated patients at better rates and at lower energy settings than a monophasic damped sine (MDS) waveform. The Zoll RBW, at an energy of 120 joules, was able to terminate ventricular fibrillation in a greater number of patients on the first shock than the MDS waveform at an energy setting of 200 joules (67% vs. 48%). Also at the meeting, Zoll presented study results that showed lay rescuers followed more steps in the Chain of Survival (part of guidelines from the American Heart Association) using the Zoll AED Plus than other automated external defibrillators (AEDs). The Zoll AED Plus helped study participants improve chest compressions during cardiopulmonary resuscitation, with an average 250% increase in the depth of compression. There was no improvement in compression with any other device used in the study, according to Zoll.