CryoCath Technologies (Montreal, Quebec) received 510(k) regulatory clearance from the FDA in May for FrostByte, a clamp ablation device to be used in the treatment of cardiac arrhythmias. The company said it expected to receive CE mark approval shortly and launch the product this month. According to Steve Arless, president and chief executive officer of CryoCath, FrostByte is the "next generation" of the company's SurgiFrost system. "What we have done," he told Cardiovascular Device Update, "is we refined the SurgiFrost design. We extended the cooling section by 25% to make longer lesions more quickly and we've also built it into a clamp device."
Cryotherapy, or the use of "cold energy," is thought to be able to preserve the structural integrity of tissue by selectively destroying the cellular components through intra- and inter-cellular ice formation while leaving intact the connective tissue matrix. Additionally, cryotherapy shows potential to greatly minimize one of the most harmful side effects of heat-based catheter treatments thrombosis, or blood clot formation, which can lead to stroke.
Arless said two radio frequency bipolar systems, one by Medtronic (Minneapolis, Minnesota) and the other by Atricure (West Chester, Ohio) control about 50% of the surgical ablation market and they both employ clamp devices. "Cryo is the preferred energy source for the surgical ablation of cardiac arrhythmias, and currently a clamp system is the most popular approach to ablate atrial tissue," he said. "The combination of these two elements in one cryoablation device is a critical component of our longer-term strategy to become the dominant player in the atrial fibrillation market. In the nearer term, regulatory clearance of this product in both the U.S. and in Europe will help us accelerate our growth rates in our surgical business in the second half of this year and beyond."
Separately, CryoCath reported that the first 13 patients in a human feasibility study using its Arctic Circler Balloon catheter for atrial fibrillation (AF) have been treated. The trial will treat up to 20 AF patients at two centers in Europe and is expected to complete enrollment this month. The trial's endpoints will be safety and efficacy. The study's protocol also allows the use of the company's two other catheters, Arctic Circler Linear and Freezor MAX. CryoCath said it intends to use the data from this trial to apply for regulatory approval in Europe in 1Q05, and to have Arctic Circler Balloon included in the final protocol for its pivotal FDA study for the treatment of AF using a toolbox approach, starting in 1Q05.
CryoCath also said that it has completed enrollment in the first stage of its two-part investigational device exemption study for the treatment of AF. The study involves a "tool box" approach for treating AF using up to three different catheters: Arctic Circler, Freezor Xtra and Freezor MAX. The first stage of the study, designed to establish the safety and viability of the tool box approach, enrolled 24 patients at two U.S. centers. Initial results showed a 95% acute success rate in achieving electrical isolation in all treated veins. There also was a 95% success rate in establishing a flutter ablation line in the right atrial isthmus to proactively prevent atrial flutter, which often triggers AF events. There were no reports of serious adverse events.
Elsewhere in the product pipeline:
AGA Medical (Minneapolis, Minnesota) has received FDA clearance for its Amplatzer Vascular Plug, an implantable device that provides physicians with a minimally invasive alternative to current options for correcting common vascular disorders. The approved application is to occlude specifically targeted veins and arteries for cases where the site to be treated is within the peripheral vasculature. The Amplatzer Vascular Plug is introduced to the target vessel via a catheter threaded through a vein or artery, accessed via a small incision in the patient's groin. The plug can be placed or repositioned, if necessary, and finally released in a precise manner. The self-expandable, cylindrical device is made of super-elastic Nitinol-wire mesh in diameters ranging from 4 mm to 16 mm. The device is non-magnetic and therefore compatible with magnetic resonance imaging technology.
AngioDynamics (Queensbury, New York), a wholly owned subsidiary of E-Z-EM, reported the release of the Mariner angiographic catheter, a hydrophilic-coated angiographic catheter designed to deliver contrast media to anatomy that is difficult to reach. The Mariner catheter will be available in limited distribution within the U.S. and internationally. The Mariner angiographic catheter features AngioDynamics' patented Soft-Vu technology an atraumatic Super-Radiopaque tip, which is highly visible under fluoroscopy combined with Duration coating technology. The Duration hydrophilic coating technology significantly reduces catheter surface friction, permitting smoother navigation through challenging vasculature with optimal handling and control.
Angiolink (Taunton, Massachusetts) said it has filed a premarket approval (PMA) application with the FDA for its EVS vascular closure system. The private company, which is developing wound management and interventional cardiology products, said it expects to receive approval by early autumn for percutaneous femoral artery closure. "This is a major milestone in Angiolink's history and the last hurdle to the market launch of the EVS in the U.S.," said Jim Lousararian, president and chief executive officer. "The EVS [for expanding vascular stapling system] represents a breakthrough technology that will provide significant patient benefits in the over 8 million catheter-based procedures performed each year."
Boston Scientific (Natick, Massachusetts) reported that it has completed enrollment in ARRIVE, a peri-approval registry. ARRIVE was designed to collect and analyze "real world" clinical outcomes data for the Taxus Express2 paclitaxel-eluting stent system in the treatment of patients with coronary artery disease. The ARRIVE registry has enrolled 2,589 consecutive patients at 50 sites in the U.S. The ARRIVE registry was initiated in cooperation with the FDA. The company said it expects to announce 30-day results at the 2004 Transcatheter Cardiovascular Therapeutics conference in Washington in September.
Cardima (Fremont, California) said doctors at Lenox Hill Hospital (New York) reported two successful less-invasive cases using the company's Surgical Ablation System (SAS) to treat atrial fibrillation. Cardima's SAS ablates cardiac tissue during heart surgery using radio frequency energy. Didier Loulmet, MD, chief of the Minimally Invasive Robotic Cardiac Surgery Program,and head of the Atrial Fibrillation Program at Lenox Hill, recently applied the Cardima Surgical Ablation technology in two AF cases during a mini-thoracotomy, or less invasive approach. Loulmet said, "The ease of use, power, and depth of penetration is impressive. Because Cardima's SAS is flexible and has a very low profile, it allows multiple opportunities to access the heart to treat AF. This unique versatility gives us the ability to use this technology on both the 'open' and the 'less invasive' procedures." Separately, Cardima said it sponsored a symposium on new advances in linear ablation for atrial fibrillation at the Heart Rhythm Society meeting in San Francisco, California. Researchers reported acute success on achieving pulmonary vein isolation using Cardima's Helix STX 2.5 microcatheter with 16 3 mm electrodes and Intellitemp, the company's radio frequency (RF) energy management system. Researchers found a 70% reduction in ablation time when the electrodes were energized by Intellitemp, as compared to his use of a manual switchbox controller. The company said this was the first study demonstrating results of the Cardima Ablation System used as originally intended: multi-electrode mapping and ablation with the same device using the Intellitemp to control RF energy delivery.
CardioTech International (Wilmington, Massachusetts) reported that the first publication of data from human studies using the Gish Biocompatible Surface (GBS) heparin coating developed by its subsidiary, Gish Biomedical (Rancho Santa Margarita, California), was presented at the Mechanisms of Perfusion meeting in Orlando, Florida. The coating is used on cardiopulmonary bypass circuits and provides protection for the patient's blood during open-heart procedures. The study authors concluded that the GBS heparin coating provided an unmatched combination of hemo- and biocompatible surface for cardiopulmonary bypass circuits, with better protein and platelet conservation, compared to both uncoated circuits and a competitive heparin coating.
CoreValve SA (Paris) said it is seeking Institutional Review Board approval from two undisclosed medical institutions related to its proprietary self-expanding stented heart valve, to be implanted in a human using the CoreValve Percutaneous ReValving System in a cardiac catheterization laboratory. The company said it expects that the patient selected will be able to avoid open-heart surgery to treat aortic stenosis. The first-of-its-kind procedure on a human is expected to be performed this month. CoreValve unveiled its technology in late May at EuroPCR Cardiovascular Congress in Paris.
Daxor (New York) reported a new study involving blood volume measurement and the survival of congestive heart failure patients in The American Journal of Cardiology. Daxor's semi-automated BVA-100 Blood Volume Analyzer was used to measure the degree of blood volume expansion in congestive heart failure patients and the eventual outcome. The patients had a median follow-up for a total of 719 days. During the first year, the major finding was a 39% death rate in patients that were hypervolemic vs. 0% death rate for those who were normovolemic/ hypovolemic. The study also found that physicians were only correct 51% of the time in categorizing the blood volume status of the patient.
Endologix (Irvine, California) reported details of its U.S. pivotal trial with the PowerLink system endoluminal stent graft (ELG) for the minimally invasive treatment of abdominal aortic aneurysms. Results of the trial were presented at the recent Eastern Vascular Society meeting in Philadelphia, Pennsylvania. The pivotal trial enrolled 193 test patients and 66 controls treated by conventional surgery. Among other results, the study demonstrated that the PowerLink System was successfully deployed in 97.9% of test patients; and operative times, ICU time, blood loss and hospital length-of-stay for PowerLink System patients was significantly lower vs. control patients.
ev3 (Plymouth, Minnesota) said it has received CE mark approval for the Protege GPS Nitinol Self-Expanding Stent for use during carotid stenting procedures, which are minimally invasive procedures to open blockages in carotid arteries and reduce stroke risk. The Protege Nitinol Self-Expanding Stent is implanted into the carotid artery and designed to keep the vessel open and allow blood flow. The company said it plans to introduce the product in Europe this month.
Medtronic (Minneapolis, Minnesota) reported the European market release of the high-energy Intrinsic implantable cardioverter defibrillator, the first ICD with Managed Ventricular Pacing (MVP). MVP is a new pacing mode designed to promote natural heart activity by minimizing unnecessary right ventricular pacing, accomplished by automatically switching between single- and dual-chamber pacing based on specific patient needs. The MVP mode can reduce the amount of ventricular pacing to less than 5%, compared to 50% or more with typical dual-chamber pacing. The device offers 35 joules of energy, a small 38 cc size and a typical longevity of up to eight years.
Myocor (Minneapolis, Minnesota) reported that the U.S. Patent and Trademark Office has issued the company patent No. 6,723,038, titled "Methods and devices for improving mitral valve function." The patent covers methods for improving heart valve function using a device to alter the shape of the valve and adjusting the device based on real-time ultrasound imaging. In related news, the company reported that more than 50 patients have been implanted with its Coapsys device. The Coapsys technology is designed to geometrically reshape the mitral valve and to improve valve function using a less invasive approach compared to current therapies. The Coapsys device is implanted on a closed, beating heart without the use of cardiopulmonary bypass.
OmniSonics Medical Technologies (Wilmington, Massachusetts) reported that it has been granted two U.S. patents relating to its OmniWave Technology Platform. Patent No. 6,730,048, titled "Apparatus and method for ultrasonic medical device with improved visibility in imaging procedures," provides for a proprietary capability that allows an ultrasonic medical device to be guided and placed accurately during minimally invasive endovascular procedures to remove occlusions from blood vessels. Patent No. 6,733,451, titled "Apparatus and method for an ultrasonic probe used with a pharmacological agent," covers the use of an ultrasonic device with the delivery of agents that may, for example, further aid in the dissolution of occlusions.
Orbus Medical Technologies (Fort Lauderdale, Florida) said it has concluded its Direct Stenting Study with the Orbus R stent (DIRECTOR) trial to angiographically evaluate the performance of the R stent when implanted using the direct stenting technique. The trial enrolled 128 patients in 17 clinical sites located in nine countries. Of the patient population, 64.4% had hypercholesterolemia, 45.3% had hypertension, and 40.6% had a family history of coronary artery disease. The results from this trial demonstrate that direct stenting with the R stent is safe and effective with a high angiographic success rate, a low conversion to predilatation, and favorable long-term angiographic and clinical results.
Possis Medical (Minneapolis, Minnesota) reported that it has received FDA approval to market the rapid exchange version of its XMI Rheolytic Thrombectomy Catheter, the XMI-RX, for coronary indications. The XMI-RX had previously been labeled for peripheral arterial use. The company also reported that it has received CE mark approval, allowing coronary marketing of the product in the European Community. Possis Medical launched the XMI-RX at the euroPCR meeting in Paris late last month.
Rubicon Medical (Salt Lake City, Utah) reported that the major adverse cardiac event (MACE) rate 30 days following the procedures involving 33 initial patients enrolled in its RULE-SVG study of the Rubicon Filter in Europe was 3%. The RULE-SVG study involved the testing of the Rubicon Filter in both saphenous vein grafts (SVGs) and native coronary arteries, including high-risk stenting procedures. "After completing the procedures of the initial enrollment and monitoring the results, we have seen no major adverse cardiac events related to the Rubicon Filter in the initial patients during the 30-day follow-up period," said Eberhard Grube, MD, chief of interventional cardiology at Heart Center Siegburg (Siegburg, Germany), one of the physicians conducting the study. Separately, Rubicon Medical reported that it has completed initial enrollment for its RULE-Carotid clinical study in Europe using the Rubicon Filter in carotid arteries. The company said it expects to obtain CE mark clearance for use of the Rubicon Filter in carotid arteries near the end of 2004. Carotid artery stenting is often performed on carotid arteries that have developed blockages as a result of plaque buildup on the artery walls. The Rubicon Filter is designed to help physicians prevent embolic events from occurring during carotid. Dr. Juachim Schofer, co-founder of the Center of Cardiology and Vascular Intervention (Hamburg, Germany), the principal investigator for the trial, said, "we have seen no clinical or technical adverse effects related to the Rubicon Filter to this point." Rubicon Medical said it plans to use the collected data to generate the necessary reports and file for regulatory approval for marketing clearance for the product in Europe.
Spectranetics (Colorado Springs, Colorado) reported the first successful CLiRpath procedures using new Extreme Excimer Laser Catheters, recently cleared by the FDA, performed by Craig Walker, MD, Mohammed Khan, MD, and David Allie, MD, at Cardiovascular Institute of the South (Houma, Louisiana) and by John Laird, MD, at the Washington Hospital Center (Washington). CLiRpath Excimer Laser Catheters are indicated for use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions cannot be crossed with standard guide wires. The physicians used the larger, 2.3 mm and 2.5 mm CLiRpath Catheters introduced into the U.S. market early last month. Laird was principal investigator of the LACI (Laser Angioplasty for Critical Limb Ischemia) trial. Allie and Walker were principal investigators in the Louisiana LACI Case Series. Clinical data from a subset of patients enrolled in these trials were used to support the 510(k) clearance. Laird used a 2.3 mm CLiRpath Catheter to recanalize a 30 cm occlusion in the superficial femoral artery in a patient with an ischemic ulcer. After successful laser atherectomy, balloon angioplasty was performed without the need for a stent. Spectranetics manufactures single-use medical devices used in minimally invasive surgical procedures within the cardiovascular system in conjunction with its proprietary excimer laser system. Its CVX-300 excimer laser is the only system approved by the FDA for multiple cardiovascular procedures.
St. Jude Medical (St. Paul, Minnesota) reported FDA approval of the Riata i lead family, which the company called "the world's thinnest integrated bipolar implantable cardioverter defibrillator leads." The isodiametric body diameter of Riata i leads measures 2.2 mm or 2.5 mm (depending on model), and fits an 8 Fr introducer. The new Riata i lead family allows physicians even more versatility when managing patients with high defibrillation thresholds. The leads are multi-lumen silicone leads with St. Jude Medical's exclusive Fast-Pass coating for improved lubricity.
Thoratec (Pleasanton, California) reported the expansion of the Phase I feasibility trial for the HeartMate II left ventricular assist system (LVAS). The HeartMate II is a next-generation heart assist device designed to provide long-term cardiac support for patients with end-stage heart failure. The trial, which originally allowed enrollment of up to seven patients in four institutions, now will enlist up to 15 patients at up to 10 centers in the U.S. The company said that at least four of the additional six centers to be added to the trial have already been identified, received all necessary internal approvals, and have been trained on the technology, allowing them to begin screening and treating patients immediately. The company also reported that the FDA has approved HeartMate II patients in the clinical trial to be discharged to a home setting from the hospital, based on the positive outcomes of the trial to date.
Toshiba America Medical Systems (TAMS; Tustin, California) said a research study in the April issue of Investigative Radiology showed its SureCardio multi-segment reconstruction applications to be clinically superior to standard halfscan reconstruction of 16-slice coronary computed tomography angiography performed on its Aquilion 16 CFX CT system. Each test result revealed that multi-segment reconstruction offered significant measurable improvements over half-scan reconstruction in patients with normal heart rates and reduced the acquisition time per heartbeat. According to researchers, the results were almost completely attributable to the higher image quality of multi-segment reconstruction, which produced images of the coronary arteries free of motion artifacts. SureCardio applications enable the Aquilion CFX products to produce precise MPR images, volume curves and polar maps, as well as wall motion analysis and functional parameter calculations.
W. L. Gore & Associates (Flagstaff, Arizona) reported the addition of collagen-coated polyester vascular prostheses and vascular patches to its medical products offering. The Gore polyester product family includes collagen-coated knitted and woven polyester graft configurations for aortic procedures, as well as cardiovascular patches designed for peripheral vascular repairs.
WorldHeart (Ottawa, Ontario) said last month that it received conditional approval from the FDA to proceed with full enrollment of recipients in the RELIANT (Randomized Evaluation of the Novacor LVAS In A Non-Transplant Population) trial. The RELIANT trial, first unveiled by the company last November, will randomize patients to receive either a Novacor LVAS or a Thoratec (Pleasanton, California) HeartMate XVE LVAS on a 2:1 ratio. The Novacor system, which WorldHeart acquired from Edwards Lifesciences (Irvine, California) in 2000, is an implanted, electromagnetically driven pump that provides circulatory support by taking over part or all of the workload of the left ventricle. With implants in more than 1,500 patients, no deaths have been attributed to device failure, and some recipients have lived with their original pumps for as long as four years. The company also is developing its next-generation technology, the HeartSaverVAD, a fully implantable assist device intended for long-term support of patients with heart failure. The FDA's conditional approval for the trial permits immediate enrollment of up to 390 patients at up to 40 centers in the U.S. The primary enrollment will be 300 patients, with approximately 90 additional patients expected to be enrolled during the follow-up period.
Zoll Medical (Chelmsford, Massachusetts) unveiled CodeNet, a software system that allows hospital teams to better document, manage and review cardiac arrest event and resuscitation information, at the American Association of Critical Care Nurses' National Teaching Institute in Orlando, Florida, last month. Zoll said CodeNet is the only system that time stamps logged events and synchronizes these times with defibrillator data, providing clinicians with a complete and accurate timeline of an entire cardiac arrest event. CodeNet consists of two software applications: CodeNet Writer, which is installed on a Pocket PC-based PDA and used to log code events, and CodeNet Central, which is a database management system on a desktop or laptop computer.