CryoCath Technologies (Montreal), a company developing cryotherapy products to treat cardiovascular disease, reported that its Freezor MAX catheter has received a supplemental premarket approval (PMA) indication from the FDA, allowing it to launch its fifth product into the U.S. 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.
The Freezor MAX is indicated for minimally invasive cardiac surgery procedures, including the treatment of cardiac arrhythmias. "By providing another best-in-class device in the hands of our target physician base, we are delivering on our commitment to become the dominant player in the field of cardiac ablation," said Steve Arless, president and CEO of CryoCath. "Already a very successful product for us in Europe, we expect Freezor MAX's launch into the U.S. market to help fuel our strong commercial momentum."
Freezor MAX has been commercially available in Europe since May 2003 and the company said it has experienced strong market uptake. It is indicated for the treatment of cardiac arrhythmias and used principally to treat atrial flutter and is now CryoCath's best-selling catheter in Europe. Next to atrioventricular node reentry tachycardia arrhythmias, atrial flutter is the second most commonly ablated arrhythmia in the world.
As the name implies, Freezor MAX delivers more cooling power than the company's other U.S.-approved catheter systems, the Freezor and Freezor Xtra. By providing the maximum amount of refrigerant over a larger tip, the company said that the Freezor MAX allows physicians to make larger, deeper lesions. For the approved indication, Freezor MAX will be used to make lesions on the outside surface of heart (the epicardial surface), as well as the inside surface (endocardium). It will then be used to create a focal lesion on the epicardium or endocardium by delivering temperatures as low as -80 degrees C at its tip. The larger/deeper lesion making ability is perfectly suited, the company said, to treat arrhythmias such as ventricular tachycardia (VT), accessory pathways, atrial flutter and atrial fibrillation.
"It's going to be a nice tool for certain VTs that are very deep in the cardiac tissue and certain accessory pathways, where, perhaps, a regular Freezor catheter wouldn't be powerful enough," Arless told Cardiovascular Device Update. He said a "growing number" of deep cardiac tissue ablations are being done.
"There is no widely accepted procedure to safely ablate highly prevalent arrhythmias like VT, particularly when they originate near critical structures in the heart such as coronary blood vessels," said Patrick Tchou, MD, section head, electrophysiology & pacing, at the Cleveland Clinic Heart Center (Cleveland). "The early use of cryoablation to treat such arrhythmias has been very encouraging and a more powerful device to reach these difficult-to-reach locations in the heart has broad clinical utility."
CryoCath also said it has filed an Investigational Device Exemption (IDE) supplement with the FDA requesting the inclusion of the Arctic Circler Balloon in the "toolbox" approach in an atrial fibrillation (AF) study with the intention of treating an additional 20 patients. If approval is granted, the company expects to start enrolling patients before the end of the year. CryoCath also reported three-month chronic data from 24 patients treated at three U.S. centers using the originally contemplated toolbox: Arctic Circler Linear, Freezor Xtra and Freezor MAX. These results showed that 12 out of 24 (50%) patients experienced improvement, with 25% AF-free and 25% with reduced burden.
Elsewhere in the product pipeline:
The diagnostics division of Abbott Laboratories (Abbott Park, Illinois) has expanded the product offering for its AxSYM automated immunoassay system with an updated test for the detection of cardiac troponin. The company is now ready to market its new AxSYM Troponin-I ADV, which replaces its current troponin test. According to Abbott, the new assay provides initial results within 15 minutes and offers improved detection of cardiac troponin, a protein released from dying heart muscle cells that are deprived of blood flow during a heart attack. The company received 510(k) clearance from the FDA in early September. "We are very excited," Mike Davison, immunochemistry operations manager, cardiac, told CDU. "This fits into our design of having great performing assays. With this one specifically, we have optimized the design of this assay quite significantly." Development of the updated assay took roughly 16 months, and the company plans to phase out the older test, he said.
Boston Scientific (Natick, Massachusetts) report- ed the start of enrollment in the ARRIVE 2 registry program, which plans to enroll 5,000 patients at about 60 centers in the U.S. The program is designed to collect and analyze "real world" safety and clinical outcomes data from the Taxus Express2 paclitaxel-eluting coronary stent system in the treatment of patients with coronary artery disease.
CryoCor (San Diego) reported receiving FDA 510(k) clearance for the Breva Surgical Probe, part of its Cardiac Cryoablation System, which includes a control console and a probe/console interface. The Breva Surgical Probe is intended to be used by cardiothoracic surgeons for the treatment of arrhythmias. The device works through cryoablation, the application of extreme cold to ablate or destroy electrically abnormal cardiac and vascular tissue. The Breva Probe will be used under direct visualization to perform cardiac cryoablation procedures in the surgical setting. CryoCor also reported FDAapproval of its Model 1200 series of cardiac catheters in investigational device exemption clinical studies to treat atrial flutter and atrial fibrillation arrhythmias. The Model 1200 Catheter, which will carry the commercial name CryoBlator, uses a 10 Fr coaxial design and is available in Europe in 5 cm and 7 cm reaches and electrode sizes ranging from 6.5 mm to 15 mm. In the U.S., both 5 cm and 7 cm reaches are being studied with the 6.5 mm tip length only. These multiple product variants enable physicians to tailor cryotherapy to the specific needs of their arrhythmia patients. CryoCor's Catheter Series is used in conjunction with the company's Model 2020 Cryoablation Console to deliver medical refrigerant to the tip of the intravascular catheter.
Endologix (Irvine, California) reported that it has received a conditional approval letter from the FDA, allowing it to commercially distribute the Powerlink system, an endoluminal stent graft (ELG) for the minimally invasive treatment of abdominal aortic aneurysms (AAA). The conditions of approval require the standard continued post-marketing surveillance and annual update reports to the FDA and physician users, the company said. "Use of ELGs allows patients to avoid invasive surgery that carries well-documented high rates of morbidity and mortality by opting for a minimally invasive procedure," said Paul McCormick, president and CEO of Endologix. "U.S. patients with AAA will have access to our ELG that addresses many shortcomings of devices currently on the market," he said. The company estimated that each year about 50,000 to 60,000 of U.S. patients diagnosed with AAA undergo "highly invasive" conventional open surgery, 15,000 to 20,000 are treated with commercially available ELGs, while their physicians monitor the remainder.
Endomed (Phoenix) reported the market release of its AccuSet introducer catheter for the delivery of EndoFit Aortic Endovascular Grafts. The AccuSet catheter allows for precision positioning and control during endograft deployment. The catheter also elim- inates the need for oversizing the length of the endograft by delivering each graft along the preferred aortic axis at its precisely measured length. The company said the AccuSet consists of the most flexible, kink-free sheath available that has been coated with a hydrophilic compound to allow for superior access to small or tortuous vessels.
ev3 (Plymouth, Minnesota) has received 510(k) clearance from the FDA for the use of the company's Protege GPS Nitinol Self-Expanding Long Stents to treat malignant biliary strictures. The stents are used during a minimally invasive procedure to open strictures and blockages. The Protege GPS Long Stents also is expected to receive CE-mark approval for use in Europe to treat biliary strictures and peripheral vascular disease, including the iliac artery. The product will be offered in lengths up to 150 mm. The company said using one stent, rather than several shorter stents, simplifies the placement procedure and reduces the risk of complications. The Protege GPS is made of nitinol.
Guidant (Indianapolis) said it has begun enrollment in CAPTURE (Carotid Acculink/Accunet Post Approval Trial to Uncover Rare Events), an FDA-required post-approval study of carotid artery stenting performed by physicians from multiple specialties. The study will use Guidant's carotid stent and embolic protection system. As announced in a final decision recently, the Centers for Medicare & Medicaid Services will provide expanded payment coverage to include high-risk patients treated as part of this and other FDA-required post-approval studies of carotid artery stenting. Guidant is currently is the only company with a carotid stent and embolic protection system on the market in the U.S. CAPTURE is part of Guidant's post-approval study plan that will include at least 1,500 patients receiving the Acculink Carotid Stent System and Accunet Embolic Protection System at about 150 sites in the U.S. The primary endpoint of the study will be a composite of stroke, death and heart attack at 30 days following the carotid stenting procedure.
Kensey Nash (Exton, Pennsylvania) said it has received a comment letter from the FDA related to its application for 510(k) clearance for its TriActiv System. The company said it is preparing its response to the letter and intends to file a response within a short period of time. Based on the nature of the comments, Kensey Nash said it continues to anticipate FDA approval for the TriActiv by year-end. The 510(k) application contains data from the PRIDE (Protection during saphenous vein graft Intervention to prevent Distal Embolization) trial which randomized the TriActiv System against other approved embolic protection systems or the standard of care, and measured major adverse cardiac event rates in the treatment of saphenous vein graft disease. The embolic protection system is designed to prevent material or debris, dislodged during stent procedures, from embolizing downstream and causing adverse coronary events.
A new clinical study reported the journal Circulation shows that patients with mild heart failure may benefit from cardiac resynchronization therapy (CRT) in much the same way that those with moderate or severe heart failure do, which could substantially bolster the potential patient population who could receive one of these devices. The MIRACLE ICD II study, sponsored by Medtronic (Minneapolis), evaluated the use of cardiac resynchronization therapy defibrillators in patients with mild symptoms, and showed that these patients demonstrated significant improvement in both cardiac structure and function, as well as improvements in their overall clinical response. Moreover, the study suggests that CRT may even slow the progression of heart failure, the most rapidly growing form of cardiovascular disease in America. Currently, cardiac resynchronization therapy is approved by the FDA only for patients with New York Heart Association (NYHA) Class III and IV (moderate to severe) heart failure. These are patients who have symptoms such as breathlessness and fatigue, even during moderate exertion. Many cannot perform normal daily activities, and some are bedridden. Based on the MIRACLE ICD II study, and other ongoing studies such as REVERSE, Medtronic hopes to collect additional data needed to pursue expansion of CRT indications to Class II patients. This class represents more than 40% of the 5 million Americans who currently have heart failure, the largest of the four NYHA categories. Together, Classes III and IV total about 35% of all heart failure patients. Medtronic also reported the launch of IMPROVE HF, a landmark registry to help physicians evaluate the quality of care provided to heart failure patients and improve treatment rates for proven drug and device therapies for heart failure. IMPROVE HF will be the largest heart failure registry ever undertaken in the outpatient setting, Medtronic said. Over two years, a contract research organization will analyze about 125,000 patient records at 250 U.S. cardiology practices. IMPROVE HF is designed to capture the current state of care for Americans with heart failure, provide educational tools to clinicians to close identified treatment gaps, and measure the effectiveness of those tools.
Medtronic Vascular (Santa Rosa, California) reported that the first patient was enrolled in the MAVErIC III Clinical Trial, the third in a series of studies to evaluate a system of devices to treat blockages in the carotid arteries that can lead to ischemic strokes. The first patient implant in the trial was conducted by Robert Molnar, MD, at McLaren Regional Medical Center (Flint, Michigan). The MAVErIC III study will gather data for submission to U.S. regulatory authorities to evaluate the safety and efficacy of the Medtronic Interceptor Plus Carotid Filter System with the Medtronic Exponent Self-Expanding Carotid Stent System for the treatment of carotid stenosis. MAVErIC III will include 413 high-risk patients at 35 investigational sites in North America.
Quinton Cardiology Systems (Bothell, Washington) has started shipping the Q-Stress version 3.5 cardiac stress testing system. The company said its latest software version delivers substantial clinical and ease-of-use advantages, while providing clinicians with advanced cardiac analysis tools. Among its major enhancements are FreezeFrame, a tool that allows clinicians to perform in-test electrocardiogram (ECG) analysis by continuously storing and displaying vital information for study and archiving during the test; and Cardiac Risk Scoring, a feature using standardized scoring metrics to help predict the likelihood of future heart attacks. The new software also includes post-procedure ECG analysis and enhanced reporting and graphics tools.
Recom Managed Systems (Studio City, California) reported that its Model 100 ambulatory electrocardiograph diagnostic device now meets the applicable requirements of the FDA-recognized voluntary consensus standards for ambulatory electrocardiographs (commonly known as EC-38). Recom said it expected to complete its final series of regulatory safety tests by the end of November, which should allow for the commercialization of the Model 100 in 1Q05.
Synthetic Blood International (Costa Mesa, California) said a report of an Oxycyte study in a rat stroke model has been accepted for publication in Neurological Research. The report, "Early Administration of a Second-Generation Perfluorochemical Decreases Ischemic Brain Damage in a Model of Permanent Middle Cerebral Artery Occlusion in the Rat," is expected to be published next year. A poster containing favorable results from a study of the effects of Oxycyte on cerebral circulation in the rat was presented at the American Society of Anesthesiologists meeting in Las Vegas.
Thoratec (Pleasanton, California) reported that Everardo Flores has become the first patient ever to log 365 days of support on the HeartMate II left ventricular assist system (LVAS), its next-generation heart assist device designed to provide long-term cardiac support for patients with end-stage heart failure. Flores was the first patient in the U.S. to become involved in the Thoratec feasibility pilot study in November 2003. Then 18-year-old Flores was admitted to the Texas Heart Institute (Houston) in October 2003 with severe cardiomyopathy and in need of a transplant. Too weak to withstand the surgery, he was implanted with the HeartMate II to keep him alive while regaining his strength for heart transplantation. Because of its relative compact and efficient size, the HeartMate II can be used for a wide range of patients in need of long-term mechanical circulatory support. As of November, Thoratec said it had implanted 29 patients in its U.S. and European HeartMate II trials.
Trimedyne (Irvine, California) said the U.S. Patent and Trademark Office has allowed its patent application on a new laser angioplasty device. The patent covers optical fiber devices designed to make smooth channels through plaque deposits in arteries, without radiating heat sideways, which could harm the vessel walls. The device is designed for use with small, portable, relatively inexpensive solid-state diode or Holmium lasers. The company said the new device can be made as small as 0.7 millimeters (1/30th of an inch) in diameter, allowing it to be used in arteries too small to admit current balloon angioplasty or stent delivery catheters. It also is designed to create a channel through fully blocked vessels, allowing balloon angioplasty or stent delivery catheters to be used.
Vasomedical (Westbury, New York) reported that Phase 2 of the International EECP Patient Registry (IEPR-2) has met its enrollment target of 2,500 patients. IEPR-2 collects additional data to better characterize angina patients with coexisting heart failure and other conditions. Forty-seven centers that provide treatment with Vasomedical's EECP (enhanced external counterpulsation) systems across the U.S. participate in this voluntary registry, enrolling and following consecutive patients treated for angina pectoris. With the completion of enrollment for IEPR-2, physicians will gain additional information from the real-life experiences of cardiologists using EECP therapy to treat angina patients with heart failure. Patients are characterized by their demographics, medical history, symptom status and perceived quality of life immediately before EECP therapy, and at six, 12 and 24-months post-therapy. The registry also captures data on medication use, emergency room visits, hospital admissions and subsequent invasive treatments. Separately, Vasomedical said it launched its newest EECP therapy system at the American Heart Association scientific sessions in New Orleans in November. The Lumenair EECP Therapy System is the latest in the company's line of devices for the treatment of patients with advanced heart disease, including angina and heart failure. The Lumenair system incorporates an ergonomic design that improves patient comfort, enhances patient monitoring, increases ease of use by medical personnel, standardizes cuff pressures and reduces space requirements. President and CEO Thomas Glover said, "Lumenair's all-in-one design ... provides many of the features that cardiologists have requested, such as more comfort for the patient and a need for reduced floor space, while maintaining the elements that assure optimal delivery of our EECP therapy."
Ventracor (Sydney, Australia) reported that St. Vincent's Hospital (also Sydney) had performed two implants of its VentrAssist "artificial heart" as part of a global trial to gain European approval. The company said five implants have now been conducted since the trial began. Ventracor said it is on schedule to complete recruitment of congestive heart failure patients by next July. The VentrAssist left ventricular assist system is a centrifugal blood pump designed to provide permanent left heart support and is powered by a set of wearable batteries that last about eight hours before needing to be recharged.