Arrow International (Reading, Pennsylvania) last month reported the signing of a licensing agreement with the Cleveland Clinic Foundation (CCF; Cleveland, Ohio) for CCF's patents in the field of non-pulsatile centrifugal flow ventricular-assist devices for the treatment of congestive heart failure. And it said it has formed a related agreement for continued research and development on the CorAide VAD that has been a joint development effort of CCF and the National Institutes of Health (Bethesda, Maryland).
The CorAide device is non-pulsatile. It features a magnetically suspended flow pumping mechanism and it uses the moving blood as its lubricating system. Arrow said it considers the CorAide one of the most promising continuous-flow, bridge-to-transplant devices currently in development. The CorAide "may represent a future generation permanent ventricular-assist device if human organ systems prove to be adaptable to non-pulsatile blood flow over a long period of time," according to Arrow.
Len Golding, MD, the Cleveland Clinic researcher who led the team that developed the device, said that in in vivo trials to date, the CorAide "has shown excellent performance without the use of anticoagulant drug therapy." He said its smaller size, low power requirements and lower cost "provide a promising approach for bridge-to-transplant patients."
The initial goal of the joint CCF/Arrow development program is to commence human clinical trials of the device for patients needing ventricular support prior to receiving a donor heart. Human trials are expected to begin in Europe in the next 12 to 18 months.
Marlin Miller Jr., Arrow chairman and CEO, said the joint development project with CCF is complementary to Arrow's ongoing program to market the totally implantable LionHeart Left Ventricular Assist System, in a development program being carried out in conjunction with Penn State University's Hershey Medical Center (Hershey, Pennsylvania). Human clinical trials of the LionHeart are under way in both Europe and the U.S.
Elsewhere in the product pipeline:
Boston Scientific (Natick, Massachusetts) reported the launch of its Quantum Monorail post-dilatation balloon catheter in the U.S. The new catheter uses the same Quantum Leap balloon material found in the Quantum Ranger catheter. The Quantum Leap balloon material features Hinge Balloon Technology, which the company said offers sizing flexibility at lower pressures and minimal growth at higher pressures. This technology combines both non-compliant balloon properties with the performance characteristics of semi-compliant balloon catheters. The catheter is available in stent-matched lengths of 9 mm, 12 mm, 15 mm, 18 mm and 20 mm and in diameters from 2.5 mm to 4.0 mm. In other news, the company reported submitting an application to the FDA for an investigational device exemption of its internally developed Express coronary stent, with clinical trials expected to begin soon. The company's clinical study plan, which is subject to FDA approval, is designed to enroll 450 patients at 25 sites throughout the U.S.
Computer Motion (Santa Barbara, California) said the University of Pittsburgh Medical Center (UPMC; Pittsburgh, Pennsylvania) was the first center in the U.S. to use its Zeus Robotic Surgical System during a beating-heart cardiac bypass operation. Surgeons used the three-armed robot during the most important part of the operation – when the artery being used as the bypass graft is connected to the heart's main coronary artery. A 63-year-old male patient underwent multi-vessel off-pump coronary artery bypass surgery at UPMC Presbyterian Hospital April 5 as part of a national, multicenter trial seeking to evaluate whether the robotic system can be helpful to surgeons and be safely used for the surgical connection of the left internal mammary artery graft to the left anterior descending artery.
Cordis (Miami Lakes, Florida), a Johnson & Johnson company, received FDA approval to market its Bx Velocity coronary stent with a rapid exchange delivery system. Cordis originally received FDA approval of the stent on its over-the-wire delivery system in May 2000. The company is offering the rapid exchange delivery system to its customers in the U.S. under an exclusive agreement with Guidant (Indianapolis, Indiana) that enables Cordis to market and sell rapid-exchange catheters and stent delivery systems. The stent already has the CE mark. The current system is indicated for treatment of abrupt and threatened vessel closure in patients with failed interventional therapy in lesions (< 30 mm in length) with reference diameters in the range of 2.25 mm to 4.00 mm. This stent is available in lengths of 8 mm,13 mm, 18 mm, 23 mm, 28 mm and 33 mm and can be used with a 5 Fr guiding catheter up to 3.5 mm in diameter.
Corgenix Medical (Denver, Colorado) reported receiving FDA 510(k) approval to market two new test kits for the diagnosis and risk assessment of certain cardiovascular disorders characterized by blood clot formation. Corgenix said it will begin manufacturing, distributing and marketing the tests through its worldwide distribution network immediately. The new tests, IgG anti-Prothrombin and IgM anti-Prothrombin (aPT) antibody test kits, are part of Corgenix's ELISA diagnostic assays for anti-phospholipid antibody detection sold to clinical laboratories. Corgenix said these are the first anti-Prothrombin tests to have received FDA clearance. They detect key markers in the blood of patients who are at risk of developing clinical thrombosis, which can lead to heart attacks, stroke and deep vein thrombosis.
CryoLife (Kennesaw, Georgia) said it has received CE mark approval allowing for the European distribution of its Model 700 SynerGraft tissue-engineered pulmonary heart valves. CryoLife said the Model 700 SynerGraft valve represents a major development in tissue-engineered replacement biologic devices for repair of damaged or diseased human tissues. It incorporates the use of a porcine pulmonary heart valve that has been depopulated of its porcine cells, leaving a collagen matrix that has the potential to repopulate with the recipient's own cells, providing a bioengineered human heart valve with structure and biodynamics similar to the recipient's own heart valve. The company said it is anticipated that the tissue-engineered valve will have the capability to grow with the maturing of a child, thus potentially avoiding a series of heart-valve replacement procedures. Steven Anderson, CryoLife president and CEO, said the addition of the Model 700 SynerGraft pulmonary heart valve demonstrates the potential for expansion of the SynerGraft technology platform. CryoLife now provides two tissue-engineered heart valves for patients requiring heart valve replacement: the SynerGraft Model 500 aortic valve and the Model 700 pulmonary valve. Anderson said that in advanced animal studies, "both of these valves have been repopulated with the recipient's own cells." CryoLife scientists and regulatory personnel are working on development of additional SynerGraft Model 500 and 700 clinical data relating to an investigational device exemption application to the FDA to use Model 500 and 700 pulmonary heart valves in human clinical trials. The IDE applications are expected to be made in 4Q01.
Guidant (Indianapolis, Indiana) reported CE mark approval and European market release of its Multi-Link Pixel 2.0 mm coronary stent system, a new stent that the company said will allow physicians to treat a wider range of coronary blockages. Guidant said it also has filed for FDA approval of the Multi-Link Pixel in 2.0 mm, 2.25 mm and 2.5 mm sizes. The CE mark approval of the 2.0 mm stent covers use for treating abrupt or threatened abrupt closures, which are arteries at risk of suddenly closing. This approval also will allow use of the 2.25 mm and 2.5 mm sizes for treating abrupt or threatened abrupt closures. The two larger sizes received CE mark approval in October 2000 and previously were approved only for use in treating first-time coronary blockages. The Multi-Link Pixel, Guidant's smallest stent, was specifically designed for small vessels, which it said represent about 25% of the 1.5 million coronary interventions performed worldwide each year.
Imatron (South San Francisco, California) said that its proprietary electron beam tomography (EBT) technology was featured in more than 20 presentations, posters and debates during this year's scientific sessions of the American College of Cardiology in Orlando, Florida.
Interleukin Genetics (Waltham, Massachusetts) reported receiving U.S. patent No. 6,210,877 for the discovery that certain IL-1 gene variations increase the risk for heart disease. Studies have demonstrated that certain variations in the IL-1 gene can amplify inflammation in the arteries, thus making an individual two to four times more likely to develop clinically significant heart disease prior to age 60.
Medtronic AVE (Santa Rosa, California) said it has received FDA approval to commercialize its S7 with Discrete Technology coronary stent systems. The S7 coronary stent succeeds the S670 coronary stent. This stent is intended for use in percutaneous transluminal coronary angioplasty. The device is available in both over-the-wire and rapid exchange versions. The stent is available in diameters of 3.0 mm, 3.5 mm and 4.0 mm and in lengths of 9 mm, 12 mm, 15 mm, 18 mm, 24 mm and 30 mm. The company also said it has opened the DISTANCE trial (Direct Stenting with Angiographic and Clinical Evaluation of the S7) in markets outside of the U.S. This study is evaluating the use of the S7 in direct stenting procedures. The S7 stent is not currently approved for direct stenting in the U.S.
Medwave (St. Paul, Minnesota) said it has submitted a 510(k) notification for pediatric use of its Vasotrac APM205A continual noninvasive blood pressure monitor to the FDA. Vasotrac is designed for measuring a patient's blood pressure on a continual basis, with updates available approximately every 15 heartbeats. The device is being used in anesthesiology, critical care, emergency rooms and cardiology departments in several countries. It has been approved for adult use in the U.S.
NeuroVasx (Plymouth, Minnesota) reported the launch of its NeuroEdge catheter, the latest in a line of microcatheters designed for diagnosis and treatment of cerebrovascular disorders, including stroke. Jeffrey Lee, NeuroVasx president and CEO, said, "the extremely low profile of the NeuroEdge catheter is a distinct advantage in the precise delivery of materials far distal in the neurovasculature where very small, tortuous vessels are present." NeuroVasx is a development stage company focused on developing and marketing catheter and implant technologies to treat acute stroke, aneurysms and other cerebrovascular disorders.
Nortran Pharmaceuticals (Vancouver, British Columbia) has begun a Phase I trial of RSD1235 for treatment of acute atrial fibrillation. The randomized, placebo-controlled, dose-escalating trial will investigate the compound's safety in 38 volunteers.
Optical Sensors (Minneapolis, Minnesota) has received clearance from the FDA to market a miniaturized version of its CapnoProbe Model 2000. With its proprietary CapnoProbe Sensor, this instrument provides a measurement of sublingual CO2 levels. The company said tissue CO2 as measured with the CapnoProbe Sensor correlates with other more invasive and costly indicators of a patient's changing condition. Clinical studies indicate that rapidly deployable, early perfusion indicators may allow quicker, more effective intervention by medical personnel in critical situations. Optical Sensors said the original concept for the device came from the Institute of Critical Care Medicine, a nonprofit research and education center in critical care medicine. The CapnoProbe Sensor Model 2000 System reduces the size of the CapnoProbe instrument from a bench-top instrument to a hand-held, battery operated instrument. OSI said it is holding discussions with potential distribution partners for the CapnoProbe sensor.
PLC Systems (Franklin, Massachusetts),said that on March 12, Dr. Stephen Boyce, director of heart transplant and circulatory assist device programs at the Washington Hospital Center (Washington), performed the first carbon dioxide (CO2) transmyocardial revascularization (TMR) surgery using PLC's next-generation CO2 Heart Laser 2. Boyce performed TMR on a 57 year-old male with complicated coronary artery disease. The patient was discharged home four days later, following an uneventful post-operative course. The patient remains angina-free at home. The CO2 TMR therapy is a surgical procedure that the company said improves blood flow to the myocardium of the left ventricle of the heart, which relieves chest pain in severely debilitated heart patients.
Scios (Sunnyvale, California) said the FDA's Cardiovascular and Renal Drugs Advisory Committee will review its new drug application amendment for Natrecor (nesitritide) for treatment of congestive heart failure on May 25.
Spectranetics (Colorado Springs, Colorado) said that an article in the April 1 issue of the American Journal of Cardiology demonstrated the safety and effectiveness of excimer laser coronary angioplasty to treat a subset of patients with acute coronary syndromes. The article valuated the feasibility, safety, and acute results of percutaneous excimer laser coronary angioplasty (ELCA) in acute coronary syndromes. Fifty-nine patients were treated with ELCA, including 33 patients with unstable angina pectoris (UAP) and 26 patients with acute myocardial infarction (AMI). The study showed procedural success rates of 100% and 97% for the AMI and UAP groups, respectively. Spectranetics is a medical device company that makes products that deliver excimer laser energy for minimally invasive surgical procedures within the cardiovascular system.
Thoratec (Pleasanton, California) said that a 61-year-old German man suffering from ischemic cardiomyopathy was the first patient in Europe implanted with the company's HeartMate II, a second-generation left ventricular-assist system (LVAS). The company will be seeking approval to market and sell the device as a long-term cardiac support system for critically ill heart failure patients, including those not eligible for a heart transplant. The first implant of the system occurred last year in Israel. The device , which consists of a miniature rotary blood pump, weighs approximately 12 ounces and is about 1.5 inches in diameter and 2.5 inches long. Since it is small, the device can accommodate even small adults and children.