Industry News and Products
Endocare and Cryocath Form Strategic Alliance to Penetrate Surgical Cardiac Arrhythmia Market
Endocare, Inc. and CryoCath Technologies Inc. have jointly announced that they have formed a strategic alliance with the signing of a five-year exclusive global supply and market access agreement.
Under the agreement, the two companies, based primarily on the Endocare proprietary cryoablation technology, will codevelop a new, advanced line of surgical probe systems to surgically treat cardiac arrhythmias, including atrial fibrillation. CryoCath will purchase the newly developed systems from Endocare and market them on a global basis under the CryoCath trademark, "Surgifrost."
CryoCath President & CEO Steven G. Arless commented, "This partnership helps advance CryoCath's strategy of being the global leader in treating cardiovascular disease with leading-edge cryotherapy technology. Adapting Endocare's state-of-the-art surgical probe systems to treat AF complements our core catheter-based platform and will enable us to maximize our penetration of this large marketplace by offering a broader portfolio of tools to clinicians."
"Our strategic partnership with Endocare has two other key advantages," continued Arless. "Firstly, we will be able to more effectively leverage our current European sales network and secondly, we will accelerate our entry into the U.S. market to 2002, better preparing our sales and marketing infrastructure for the anticipated U.S. launch of our Freezor™ catheter cryoablation system in 2003."
Endocare Chairman and CEO Paul Mikus stated, "Endocare's targeted cryoablation technology has proven to be extremely effective in treating cancer, and a natural extension of this technology is to treat cardiac arrhythmias. A practical and effective method for treating AF has been something of a Holy Grail for the healthcare industry and CryoCath and its research partners have made great strides in making such a treatment a reality. CryoCath's selection of our technology as a key part of its strategy to develop a dominant position in the arrhythmia market is further evidence of the potentially large number of possible applications for our targeted cryoablation technology. Our two companies will now be able to offer cardiac surgeons a valuable new tool to treat AF as well as other arrhythmias."
"This agreement also signifies the continuing platform expansion of Endocare's proprietary technologies into additional disease management areas," Mikus added. "As data related to the ablation of cancer and other disease treatments continues to be uniformly positive, we expect this broadening of product offerings to accelerate the implementation of our business plan and provide diversity in our revenue streams."
The impetus for this alliance stems from feedback by electrophysiology thought leaders, which suggests that clinicians will require a portfolio of tools to treat this pervasive disease. Whereas it is believed that percutaneous devices (catheters) may ultimately treat approximately 75 percent of AF patients, the addtion of a surgical probe alternative could increase the likelihood of treating virtually all AF patients.
Biotronik Receives Approval of the Belos VR Implantable Defibrillator
Biotronik, Inc. announced that the U.S. FDA has approved the Belos VR implantable cardioverter defibrillator (ICD).
The approval represents a significant milestone for the company, as Belos VR completes Biotronik's line of downsized rate-adaptive ICDs.
At 36 cc and just 12 mm thin, Belos VR is the lightest rate-adaptive ICD available on the market. The single-chamber ICD is fully featured with tiered therapy and a sophisticated tachyarrhythmic diagnostic package. Belos VR offers 30 joules of delivered energy and multiple pacing therapies to treat patients with life-threatening ventricular tachyarrhythmias. To assist the physician in clinical decision-making, the device includes a full hour of high fidelity heart rhythm recordings (IEGMs), a 24-hour Holter, exclusive time-controlled interval recordings a nd optional far-field IEGMS.
FASTWare™ software compliments the Belos VR with an intuitive, user-friendly interface. FASTware simplifies impalny and follow-up procedures providing advanced tools for troubleshooting, device-based testing and evaluation of anti-arrhythmic drug therapy.
The Belos VR joins the market-released Tachos DR in Biotronik's growing line of rate-adaptive ICD products. Biotronik continues its aggressive stance of rapidly entering the U.S. cardiac rhythm market (CRM) with new FDA approvals and ongoing clinical investigation of the Tachos DR ICD with Atrial Therapies.
Endocardial Solutions Announces FDA Clearance of Precision™ Software
Endocardial Solutions, Inc. announced that the U.S. Food and Drug Administration has cleared release of Precision™, an upgraded version of the company's software product for use in the EnSite 3000® System for diagnostic mapping of complex arrhythmias.
"I feel that the improvements embodied in the Precision™ software, specifically the greatly enhanced and more realistic chamber geometry and the new catheter positioning technique, will vastly improve orientation," said Robert Lemery, M.D., Associate Professor, Ottawa Heart Institute, Ottawa, Canada. "These new features, as well as other components of the Precision™ software, will most likely speed up our procedure times and reduce the use of fluoroscopy,'' concluded Lemery.
"We will continue investing in Research and Development to provide our customers with substantial improvements in diagnosing and treating complex arrhythmias," stated Jim Bullock, President and Chief Executive Officer. "This is another step forward in establishing the EnSite 3000® System as a mandatory tool in arrhythmia management," concluded Bullock.
Based in St. Paul, Minnesota, Endocardial Solutions develops, manufactures and markets technology for diagnostic mapping of complex arrhythmias (abnormally rapid heartbeats caused by irregular electrical activity in the heart). The EnSite 3000® System provides a three dimensional graphical display of the heart's electrical activity.
FDA Clears Medtronic InSync Device Early
Medtronic Inc. has announced that the U.S. regulators have approved its InSync pacemaker-like device, clearing the way for the company to bring the first device-based treatment for heart failure to the U.S. market.
The approval of the heart therapy device from the U.S. FDA gives Medtronic, a maker of medical devices, a leg up over chief rival Guidant Corp., which in July failed to receive a favorable ruling from an FDA panel for a similar product.
Until now, the FDA had approved only prescription drugs for the treatment of heart failure, a condition in which the weakened heart cannot adequately pump blood to the body.
Stephen Mahle, president of Medtronic's Cardiac Rhythm Management unit, said the company was "very pleased" with the FDA's speedy approval.
"The FDA did a terrific job of what I think the FDA ought to be doing, which is making sure safe and effective new therapies reach the public as quickly as possible," he said in an interview.
"This is great news for Medtronic," said William Blair & Co. analyst Benjamin Andrew. "They are at least a month, maybe three months ahead of schedule, and for a company to get approval so quickly is a strong statement by the FDA as to the safety and efficacy of this product," he said.
William Abraham, chief of cardiovascular medicine at the University of Kentucky College of Medicine, said the new therapy will benefit thousands of patients immediately.
"It reduces the number of days patients need to be hospitalized and helps reduce the enormous financial burden on the health care system," he said in a statement. Abraham was the lead clinical investigator for the study that tested the safety and effectiveness of the new therapy.
The InSync treatment is comprised of a pulse generator about the size of two stacked silver dollars that is implanted beneath the shoulder. It delivers synchronized electrical shocks to three chambers of the heart via insulated wires, enabling the heart to pump blood more efficiently.
FDA Clears Catheter to Find the "Source" of Abnormal Heart Rhythms
CathEffects™, LLC announced that they have received FDA clearance to market the Desai VectorCath' Electrophysiology Mapping Catheter.
The Desai VectorCath™ is a disposable mapping catheter for recording electrical signals in the heart during diagnostic EP procedures. The company says their catheter's proprietary five-electrode two-plane orthogonal design will improve procedural directionality, speed, and accuracy to find the source of cardiac arrhythmias.
Arrhythmias that can be mapped include, atrial tachycardia, atrial fibrillation, atrial flutter, focal and ischemic ventricular tachycardia, AV nodal reentry tachycardia, and accessory pathway induced tachycardia.
The Desai VectorCath was invented by Jawahar M. Desai, M.D., F.A.C.C., of Roseville, California and is licensed to CathEffects with 15 other patents.
"The Desai VectorCath Mapping Catheter will benefit patients with faster and more accurate electrophysiology diagnostic studies," said Shawn Fojtik, CEO. "The catheter instantly maps the heart underneath the array's five electrodes covering one square centimeter (1 cm2) of endocardium. During a procedure, one or two of the catheter's five electrodes will be closer to the arrhythmia's focus and receive the signal(s) first. The physician then moves the catheter in the direction of the earliest electrode(s) and within a few moves, the catheter is close to the focus of the arrhythmia."
Mr. Fojtik adds, "the Desai VectorCath will financially benefit patients and hospitals as it can reduce the number of traditional catheters needed to map the heart and will work with existing electrophysiology recording systems."
CathEffects' designs, develops, and manufactures electrophysiology mapping catheters, mapping systems, and ablation catheters.
EP MedSystems Submits Amendments to its Alert System PMA Application
EP MedSystems, Inc. announced the submission of two amendments to its ALERT® PMA application.
The first amendment answers questions and addresses deficiencies in the current filing with the FDA. A second amendment, expected to be submitted this week, will seek approval for market release for ALERT® Companion II, a touch screen bi-phasic defibrillator for use with the ALERT® Catheter to perform low-energy internal cardioversion in treating atrial fibrillation.
EPMD previously announced that its ALERT® System PMA application was accepted for filing by the FDA as of October 2, 2000, and that the FDA had responded with questions and noted deficiencies in its letter to EPMD on April 2, 2001. These amendments are intended to be responsive to the FDA's letter and to supplement our prior application to include the ALERT Companion II
EPMD's patented ALERT Catheter is proprietary and used in tandem with the ALERT Companion to deliver a bi-phasic low energy waveform used to convert atrial fibrillation to a normal (sinus) heart rhythm. The ALERT® System has been shown to use about 50 times less energy for cardioversion than the standard external "paddles." EPMD estimates that there are more than 5 million people worldwide with atrial fibrillation; a disease associated with reduced cardiac output, congestive heart failure, and stroke.
