The carotid artery stent system from Cordis Endovascular (Miami Lakes, Florida) is one step closer to approval by the FDA. At a meeting on April 21, the Circulatory System Devices Panel of the agency's Center for Devices and Radiological Health recommended approval of the premarket approval (PMA) application for the Cordis Carotid System, with conditions, by a narrow 6-to-5 vote. Cordis Endovascular is a division of Cordis, in turn a unit of Johnson & Johnson (New Brunswick, New Jersey). The system, already approved outside the U.S. for use in carotid arteries, is made up of two components: the Precise Nitinol Self-Expanding Stent and the Angioguard Emboli Capture Guidewire. This is the first system of its kind to be recommended for FDA approval, according to the company. The recommendation for approval was given by the panel primarily because of its application for treating a high-risk patient group.
"This is the best we could hope for and expect," Sidney Cohen, MD, PhD, group director of clinical research for Cordis, told Cardiovascular Device Update. "We are extremely happy to see this alternative method of treating patients being considered in a positive light." Conditions for approval recommended by the review panel include a clarification of eligible patients, specific indications as to when the device system should be used, a 30-day independent neurologic patient review and appropriate use of the system's distal protection device to minimize the risk of stroke.
Much of the committee's response was positive, despite debate as to whether or not the data presented proved efficacy across different patient groups. There also was some controversy as to statistical differences between the company's and the FDA's review of study data. "This is a safe and effective alternative," said panel member Mitchell Krucoff, MD, of Duke University Medical Center (Durham, North Carolina).
In related news, ev3 (Plymouth, Minnesota), a privately held endovascular medical device company, said the first patient has been enrolled in a company-sponsored carotid stenting clinical trial. The trial will team ev3's Prot g nitinol self-expanding stent with its Spider embolic protection device in a minimally invasive procedure to open blockages in carotid arteries and prevent strokes. The CREATE trial for Carotid Revascularization with ev3 Arterial Technology Evolution puts the company in direct competition with several heavy hitters already vying for a piece of this potentially lucrative pie, including Cordis Endovascular, Guidant (Indianapolis, Indiana) and Boston Scientific (Natick, Massachusetts).
A total of 40 U.S. hospitals will participate in the ev3 trial and enroll around 420 patients who have blockages within their carotid arteries and are at high risk for an open surgical procedure. ev3 said it plans to submit trial data in an application to the FDA for marketing clearance of the carotid artery application in the U.S. An estimated 20% to 30% of strokes are caused by plaque, which travels upstream through the carotid arteries to the brain.
Elsewhere in the product pipeline:
AngioDynamics (Queensbury, New York), a wholly owned subsidiary of E-Z-EM, reported the worldwide market launch of the SpeedLyser Thrombolytic catheter, a catheter kit intended for the administration of thrombolytic agents into the peripheral vasculature. The SpeedLyser features slits to help evenly distribute the thrombolytic drug to the blockage. A coaxial system a dual catheter combination of a 3 Fr inner catheter within a 5 Fr outer catheter simplifies access and drug delivery across the entire blocked graft. The SpeedLyser catheter is offered in lengths of 10 cm, 15 cm and 20 cm. AngioDynamics also reported the limited availability of the Morpheus peripherally inserted central catheter (PICC), a device used to obtain short- and long-term peripheral access to the central venous system for intravenous therapy and blood sampling. The Morpheus PICC is constructed of Durathane material, which offers increased stiffness for ease of placement while providing patient comfort and also helps simplify site care with easy cleaning. Featuring the company's Flextone technology, the Morpheus PICC is designed to provide a flexible catheter tip that helps minimize risk of vessel wall damage.
ATS Medical (Minneapolis, Minnesota) said the intermediate-term clinical performance of the ATS Open Pivot Heart Valve was the subject of a study published recently in the Journal of Heart Valve Disease. The authors observed, "This report . . . reveals ongoing excellent performance of the ATS mechanical prosthesis. The current follow-up over the intermediate term indicates continued durability, a low incidence of valve-related events, and excellent hemodynamics. The patients' quality of life was also improved."
Biomed Research (Tampa, Florida) reported completion of ergonomic refinements to its MedClose Internal Puncture Closure device. The MedClose is a catheter-based debridement and biological glue delivery system designed to rapidly seal arterial puncture sites following angiography and angioplasty. Design enhancements include further miniaturization to permit use with a broader range of introducer sizes, ease of use ergonomics permitting true single-user operation, distal guidewire for centering the intraluminal balloon, and refinement of the patented debridement feature to initiate release and interaction of the patient's tissue factor with Tisseel VH Fibrin Sealant (from Baxter Healthcare; Deerfield, Illinois), for rapid activation and sealing. Following completion of the preclinical and animal testing of the refined MedClose, the company said it would file an application for a human study permit with the FDA.
Boston Scientific (Natick, Massachusetts) reported 30-day safety data from its clinical trial to evaluate the benefits of stenting in conjunction with embolic protection for the treatment of carotid artery disease at the recent Peripheral Angioplasty and All That Jazz meeting in New Orleans, Louisiana. The carotid stenting trial, known as BEACH, examines the use of Boston Sci's Carotid Wallstent Monorail Endoprosthesis in combination with its FilterWire EX and EZ Embolic Protection Systems for treating patients who are at high-risk for carotid endarterectomy. Researchers reported the 30-day composite endpoint of cumulative mortality and morbidity as 5.4% of patients in the 747-patient trial. This early safety data is consistent with the study's primary endpoints and compares favorably to other high-risk carotid artery stenting trials, the company said. One-year BEACH trial results will be available in 2Q05.
CardioDynamics (San Diego, California) reported publication of seven peer-reviewed articles in Congestive Heart Failure March/April 2004 supplement. The articles demonstrate the accuracy of the company's Impedance Cardiography (ICG) technology compared to the direct Fick and thermodilution methods of determining cardiac output; ability to simply and cost-effectively identify changes in heart function compared to echocardiography; utility in differentiating diagnosis of patients with shortness of breath; ability to replace pulmonary artery catheterization, which has tremendous cost implications for hospitals; and prognostic role of changes in ICG parameters in patients with chronic heart failure.
Cardiome Pharma (Vancouver, British Columbia) said its independent Data Safety Monitoring Board recommended the company continue its ACT 1 Phase III trial, which is evaluating intravenous RSD1235 for acute atrial fibrillation and atrial flutter. The recommendation was based on a second planned safety analysis of data from 180 patients. ACT 1 will enroll about 360 patients for atrial fibrillation, with another 60 enrolled for atrial flutter in a subset called Scene 2. Cardiome expects results to be available in 4Q04.
CardioTech International (Wilmington, Massachusetts) said its wholly owned subsidiary, Gish Biomedical (Rancho Santa Margarita, California), has received FDA clearance to sell the Vision Blood Cardioplegia (VBC) System with GBS (Gish Biocompatible Surface) blood compatible coating in conjunction with Gish's line of heart bypass products. The VBC System's heat exchange design offers greater than 90% heat exchange efficiency at 250 mL/min and has a maximum rated flow rate of 600 mL/min. The company noted that the system offers an integrated bubble trap, complete visibility to the blood path and one-handed installation into the VBC Quick Lock Holder. The VBC also is available in a variety of tubing configurations to meet individual patient needs. The GBS coating is a heparin-based coating developed by Gish, a company acquired by CardioTech in March 2003. GBS is composed of heparin and hyaluronic acid, or hyaluronan. Hyaluronan is a biopolymer that occurs naturally in the human body. Because it is found in extracellular matrices and lacks immunogenicity, hyaluronan is an ideal candidate for blood-contacting applications. Separately, CardioTech International said that the first three adult patients enrolled in Brazilian clinical trials for its coronary artery bypass graft have reached the six months milestone. All are living normal lives, the company said. All three patients were diabetic and considered no-option/re-do patients, or patients who had used all available veins in their body in previous coronary bypass surgeries.
CardioVations (Somerville, New Jersey), a division of Ethicon, a Johnson & Johnson (New Brunswick, New Jersey) company, reported the latest advancement to its line of heart stabilization systems. The Embrace Heart Stabilizer stabilizes desired areas of the heart, which in turn creates a relatively stationary coronary artery during beating-heart or "off-pump" coronary bypass surgery. The device uses stabilization "feet" to hold in place the epicardium parallel to the coronary artery, allowing surgeons to bypass the blocked artery without resorting to the traditional method of stopping the heart and employing a heart/lung machine. The Embrace stabilizer includes a 360-degree rotation and tilt for optimal visualization and access to lateral wall vessels. The malleable foot pods allow for custom contouring to the epicardial surface and the low-profile suction pods gently spread tissue at the anastomotic site. The redesigned low-profile stabilizer arm provides for quick, one-step stabilization and control with an activation lever.
A team of physicians at Thomas Jefferson University Hospital (Philadelphia, Pennsylvania) completed the first U.S. placement of the Zenith TX2 Thoracic TAA Endovascular Graft under the device's pivotal U.S. clinical trial sponsored by Cook (Bloomington, Indiana). The FDA originally granted Cook an investigational device exemption (IDE) for a pivotal clinical investigation of its endovascular graft for thoracic aortic aneurysms (TAAs) in December 2003 and the company has been able to expand the study since then. The initial procedure, performed by a surgical team headed by Joseph Lombardi, MD, chief of vascular surgery in the Methodist Hospital Division of Thomas Jefferson University Hospital, took place March 30. "It is a precise system with a very satisfying delivery," Lombardi said. "Despite having to use an iliac conduit for access, the procedure was very straightforward and the patient was virtually pain-free." The Zenith, already approved for commercial distribution in Canada, Australia and Asia, incorporates clinically proven technologies to treat TAAs without the need for open surgical repair. TAAs, which are diagnosed in more than 20,000 U.S. patients annually, occur when a section of the aorta weakens and bulges outward like a balloon in the section of the artery that runs through the chest. Should the aneurysm grow to the point where it ruptures, the patient would be at high risk for rapid death due to internal bleeding. Patients diagnosed with a TAA traditionally have had to undergo a highly invasive open surgical procedure where a surgeon opens the chest cavity, clamps off the aorta and sews a surgical graft in place to prevent the aneurysm from rupturing. According to the study's national principal investigator, Jon Matsumura, MD, associate professor of surgery at Northwestern University's Feinberg School of Medicine (Chicago, Illinois), the clinical trial of the Zenith will include 220 patients at up to 35 U.S. medical institutions. "This research may demonstrate that there are significant benefits with the minimally invasive approach." Through the original IDE, Cook received conditional approval to begin a clinical trial of the Zenith involving 140 subjects at 20 U.S. medical institutions.
Patient enrollment is under way in a significant new registry that will evaluate the impact of stent-deployment technique on patient outcomes using the Cypher sirolimus-eluting stent distributed by Cordis (Miami Lakes, Florida). The eCYPHER S.T.L.L.R. registry, sponsored by Cordis, is the first study in the U.S. specifically designed to study the "real life" effect that stent-deployment technique has on patient outcomes and what can be done to more effectively place the devices in patients. The prospective, nonrandomized study will include about 1,500 patients at 50 U.S. treatment centers. "Findings from earlier Cypher stent trials strongly suggest that refinements in stent-deployment technique can further enhance the positive long-term outcomes recorded to date in patients who receive a Cypher stent," said Dennis Donohoe, MD, Cordis' vice president of regulatory and clinical affairs. "Our goal with the [registry] is to focus on technique and better define procedures that help to ensure the best possible results for patients," he said. The primary study endpoint for the registry, according to Donohoe, will be target lesion revascularization, defined as reblockage significant enough to require retreatment.
Edwards Lifesciences (Irvine, California) reported the first implant of its Carpentier-Edwards Perimount Magna replacement tissue heart valve that also features its newly approved ThermaFix tissue process, which is designed to greatly reduce tissue valve calcification. The procedure was performed by Delos Cosgrove, MD, chairman of the department of thoracic and cardiovascular surgery at the Cleveland Clinic Foundation (Cleveland, Ohio). The Perimount is an aortic replacement tissue heart valve constructed of bovine pericardium that was specifically designed to optimize patient blood flow. The device was cleared for sale by the FDA last November. The Magna was designed to replace Edwards' original 22-year-old Perimount valve, currently the top seller in the U.S. heart-valve market, but the company said a transition to the new product probably would take some time. The Magna valve's primary advantage over the Perimount is that it allows greater blood flow through the heart after it is surgically attached. Edwards' ThermaFix process, approved by the FDA in February, is intended to reduce tissue calcification, one of the primary causes of valve deterioration. The ThermaFix process was co-developed with Edwards by Professor 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.
EndoBionics (San Leandro, California) reported that the FDA has approved marketing of the company's MicroSyringe catheter for the infusion of therapeutic and diagnostic agents that are indicated for delivery into the vessel wall or perivascular area. The MicroSyringe is a wire-guided needle injection catheter that is threaded through the blood vessels to the deep tissues of the body, including the heart and other major organs. For the first time, physicians are able to inject drugs directly via the vasculature into the deep tissues of the body without major surgery, the company said. Instead, the physician positions the device in the vessel of interest, deploys its microneedle through the blood vessel wall and delivers the drug directly to the targeted tissue.
Guidant (Indianapolis, Indiana) reported completion of enrollment in SPIRIT FIRST, a clinical trial evaluating its second drug-eluting stent system for the treatment of coronary artery disease. The trial compares an everolimus-eluting stent system using Guidant's cobalt chromium Multi-Link Vision Coronary Stent System platform with a durable polymer drug carrier, vs. an uncoated Multi-Link Vision stent control. The SPIRIT FIRST study enrolled a total of 60 patients at multiple sites in the Netherlands, Denmark and Germany. The primary endpoint of the study is in-stent late loss at six months. Data from the trial will support filings for both a pivotal trial to obtain approval to market the product in the U.S. and a larger European study to support market launch outside of the U.S. Separately, Guidant reported it has received FDA market approval for its Vitality 2 implantable cardioverter defibrillator (ICD), designed to treat patients at risk for sudden cardiac death due to arrhythmia. The size and physiologic shape of the Vitality 2, the smallest and thinnest ICD on the market at 30 cc and 11 mm, is designed to facilitate ease of insertion and contribute to patient comfort. The Vitality 2 system also incorporates the company's Rhythm ID feature, which uses rhythm discrimination technology to help manage complex arrhythmias for people at risk of sudden cardiac death. Full market launch of the Vitality 2 is scheduled for this month. Guidant also reported CE mark approval of its Multi-Link Frontier Coronary Bifurcation Stent System, which is designed to treat plaque in coronary arteries at the site of a bifurcation, where one vessel branches from another. The new stent system will be immediately available in Europe, Australia and New Zealand, with expansion soon to additional countries in Asia and the Middle East.
Kensey Nash (Exton, Pennsylvania) said enrollment has been completed in the randomized trial of its TriActiv Balloon Protected Flush Extraction System. The PRIDE (PRotection during saphenous vein graft Intervention to prevent Distal Embolization) trial randomized TriActiv against other approved embolic protection systems or the standard of care, measuring major adverse cardiac event (MACE) rates in the treatment of saphenous vein graft disease. The PRIDE study enrolled 894 patients at 68 sites in the U.S. and 10 sites in Europe. The TriActiv System is designed to prevent debris, liberated during a stent procedure, from embolizing and causing a MACE. Data from the trial will be used to support FDA approval of a 510(k) application, which the company said it expects to submit by June.
MedicalCV (Inver Grove Heights, Minnesota) reported that it has filed a 510(k) application with the FDA for approval to market the Atrilaze Soft Tissue Ablation System. The laser device will be used to ablate or cause scarring of soft tissue, to include cardiac tissue, with the long-term goal of treating atrial fibrillation.
Medtronic (Minneapolis, Minnesota) reported the U.S. commercial release of two electrophysiology catheters, the EnCirclr AL Adjustable Loop Mapping Catheter and the RF Enhancer II Single-Curve Ablation Catheter. The EnCirclr AL mapping catheter is designed to identify pathways causing atrial fibrillation (AF). The RF Enhancer II ablation catheter delivers radiofrequency energy to treat various heart rhythm abnormalities. The company said both products represent advancements in detecting and treating cardiac rhythm problems caused by heart muscle cells that conduct errant electrical signals. Used prior to an ablation procedure, the EnCirclr AL offers a unique distal leader with an adjustable loop diameter that can be adjusted from outside the body to help access the most difficult-to-reach atrial anatomy. Ten electrodes on the loop identify and establish the locations of problematic cells in or around the heart. The catheter also can record intracardiac electrograms and provide intracardiac simulation. The RF Enhancer II catheter's curve tension is adjustable for optimal stability in a wide range of cardiac ablation procedures. Both products join the catheter product line designed for use with the Medtronic LocaLisa IntraCardiac Navigation System, which provides a 3-D view to build a map of the heart's chambers. Physicians may use the LocaLisa system to navigate both ablation and diagnostic catheters inside the heart. Medtronic also reported receiving approval from the Japanese Ministry of Health, Labor and Welfare to market its Sprinter Semi-Compliant Rapid Exchange Balloon Dilatation Catheter for use in coronary angioplasty procedures. The Sprinter balloon is immediately available in Japan in lengths of 6 mm, 12 mm, 15 mm, 20 mm, 25 mm and 30 mm and diameters of 1.5 mm to 4.0 mm. The Sprinter balloon provides the latest in balloon technology and is equipped to address the most difficult lesions in coronary angioplasty procedures, the company said.
Medstat (Ann Arbor, Michigan), a business of Thomson Healthcare, publisher of Cardiovascular Device Update, and ECRI (Plymouth Meeting, Pennsylvania), a nonprofit international health services research agency, reported creation of an expanded and enhanced database that enables healthcare organizations to assess the impact of emerging medical technologies. The new database, available via the Medstat Market Expert platform, integrates Medstat's market planning information with insights on technology diffusion from ECRI's Health Technology Forecast, a web-based strategic technology planning resource, as well as from ECRI's evidence-based technology assessment reports, research, and analysis. Users, who have full access to the underlying database, can customize and alter technology adoption rates in real time to test various scenarios and reflect specific clinical practices and local market dynamics.
MicroMed Technology (Houston, Texas) said a six-year-old patient at Texas Children's Hospital (also Houston) became the first pediatric patient in the world to receive its DeBakey child ventricular assist device (VAD), approved by the FDA for use in children via a Humanitarian Device Exemption (HDE). The company said the new, scaled-down heart pump improves blood flow for patients awaiting heart transplants. Designed in collaboration with the National Aeronautics and Space Administration (NASA; Washington), the Baylor College of Medicine (also Houston) and cardiac surgeons Michael DeBakey and George Noon, the DeBakey VAD Child is intended for end-stage heart failure patients who can no longer provide necessary blood flow with their native heart. The DeBakey VAD system has been awarded the CE mark for commercial distribution in Europe, with more than 240 VADs implanted worldwide. The implanted device is the size of a C battery, is silent and weighs less than four ounces. The HDE is directed toward providing transplant centers with the DeBakey VAD Child heart pumps to improve blood flow for children ages 5 to 16 who are awaiting a heart transplant. "The new procedure is a medical breakthrough in pediatric cardiac care," said Charles Fraser Jr., MD, the chief of cardiovascular surgery at Texas Children's Heart Center, who performed the surgery. "It gives new hope for children with failing hearts because they now have potential to wait longer for hearts to become available for transplants. Until now, the temporary VADs available for use only gave us a very limited timeframe for a heart to become available."
MIV Therapeutics (MIVT; Vancouver, British Columbia) reported that its Hydroxyapatite (Hap) ultra-thin coating technology has successfully passed the Systemic Injection Test, which the company said is an important milestone on the path to commercialization. The company is developing a line of next generation biocompatible coatings for stents and drug delivery systems for the treatment of cardiovascular disease. MIVT's vice president of operations, Arc Rajtar, said, "The HAp coating technology is successfully progressing through a comprehensive range of animal and mechanical trials required for CE mark and FDA approvals. To date [our] proprietary HAp coating passed thrombogenicity, cytotoxicity and demanding fatigue life testing which could be considered a benchmark for durability testing of coated stents."
PLC Systems (Franklin, Massachusetts) reported that a cardiac surgical team from Good Samaritan Hospital (Cincinnati, Ohio) has completed the first carbon dioxide (CO2) transmyocardial revascularization (TMR) procedure with robotic assistance. Dr. J. Michael Smith, a cardiac surgeon and director of robotic surgery at Good Samaritan, performed the operation using the CO2 Heart Laser from PLC to create new blood-flow channels in the heart of a 66-year-old angina patient. The patient was discharged after two days and is doing well. With visualization and several small incisions, PLC Systems said a surgeon can perform TMR with its CO2 Heart Laser, which is distributed by Edwards Lifesciences (Irvine, California), less invasively than through an open chest or thoracotomy.
Quinton Cardiology Systems (Bothell, Washington) reported that it has started shipping networked versions of its Q-Tel RMS. Q-Tel is a comprehensive, dedicated cardiac rehabilitation management system allowing clinicians and administrators to monitor patients' ECG signals in real time, quickly enter patient data, customize treatment protocols, track risk factors and report patient outcomes. The networked product enables the monitoring of up to 36 patients off the same database and workstations are now available for full remote access to the database.