GE Medical Systems (Waukesha, Wisconsin) reported last month that its GE Logiq 700 Series units will be used exclusively in the ultrasound phase of a 10-year $68 million study of heart disease and stroke risk factors funded by the National Heart, Lung, and Blood Institute (NHLBI; Bethesda, Maryland) of the National Institutes of Health (NIH). The Multi-Ethnic Study of Atherosclerosis (MESA) will investigate specific risk factors and the extent of atherosclerosis in about 6,500 men and women of varied ethnic backgrounds, ages 45-84.
The GE Logiq 700 Series units were selected from among six ultrasound vendors under NHLBI price guidelines. In the study Logiq 700 units at each of six research sites will image carotid and brachial, or upper arm, arteries to measure early atherosclerotic changes. MESA ultrasound co-investigators are Dr. Joseph Polak, associate professor of radiology at Brigham and Women's Hospital and Harvard Medical School (Boston, Massachusetts) and Dr. Daniel O'Leary, chairman of the radiology department at Tufts Medical School (also Boston). "This is an epidemiological study, and as such it requires as much quantitative data as we can get," Polak said. "Accurate measurements are very important to the quality of the data. The images we are able to produce with the GE equipment will deliver the quality of data we desire."
In addition to ultrasound studies, MESA includes the use of other noninvasive methods of evaluating risk factors, including computed tomography (CT) scanning and magnetic resonance (MR) imaging. The study also will involve blood tests, measurement of arterial waveforms and questionnaires to measure sociodemographics and psychosocial factors. MESA will observe participants with subclinical artery and heart disease – meaning disease that has not yet produced symptoms – and it will then examine specific factors that predict progression to clinical disease. About 40% of study participants will be Caucasian, 30% African-American, 20% Hispanic and 10% Asian.
Polak compared the measurement of coronary artery calcification to detecting "a rock in the coronary artery. If we identify high-risk people after they have a rock in an artery, that is really rather late. If we can learn to identify them at earlier stages of disease, we will be better able to keep them from getting into trouble." Institutions taking part in MESA are the University of California at Los Angeles, Johns Hopkins University (Baltimore, Maryland), the University of Minnesota (St. Paul, Minnesota), Northwestern University Medical School (Chicago, Illinois), Wake Forest University (Winston-Salem, North Carolina) and Columbia University (New York).
In other grant news in the cardiovascular sector:
Advanced Tissue Sciences (La Jolla, California) said it received a three-year Advanced Technology Program award of $2 million from the National Institutes of Standards and Technology (Gaithersburg, Maryland) for development of a tissue-engineered Ischemic Repair Device (IRD) to induce vascularization of and restore function to tissues and organs with reduced blood supplies. The IRD is intended primarily for cardiovascular applications but could also be used for repair of peripheral vascular tissue, such as blood vessels in the leg. The project will integrate current advances in cell culture, bioreactor technology and biomaterials to create an implantable living tissue able to respond physiologically to its environment.
SpectRx (Norcross, Georgia) has received a grant of $307,000 from the Centers for Disease Control and Prevention (CDC; Atlanta, Georgia), representing a commitment of more than $600,000 in funding to date, to adapt the company's glucose monitoring technology to monitor blood sugar levels of children and elderly people with diabetes. In collaboration with the MediSense Products Unit of Abbott Laboratories (Abbott Park, Illinois), SpectRx is developing a monitoring technology that provides continuous, painless, real-time glucose readings without requiring fingerstick blood tests. Its system uses biophotonic technology to painlessly measure glucose in interstitial fluid (ISF) rather than blood. A hand-held laser easily creates four microscopic holes in the outer layer of skin, and a patch is then placed over the holes to measure glucose concentration in a continuous stream of ISF. The grant comes from CDC's Innovative Technology Development Grants for the Detection and Monitoring of Diabetic Hypoglycemia by Non- or Minimally-Invasive Techniques
Myogen (Denver, Colorado), a developer of cardiovascular therapies, has received an NIH Small Business Innovation Research (SBIR) grant to develop compounds that inhibit a key control pathway associated with cardiac hypertrophy.. Additionally, it reported receiving a SBIR grant for research related to the long-term culture of human adult heart muscle cells. Richard Gorczynski, PhD, vice president of R&D, said, "Such cultures, in combination with our functional genomics programs focused on heart disease, provide a powerful tool for the assessment and validation of the dozen novel targets that we have already identified in our discovery research programs." The grant amounts were not disclosed. Myogen's lead product, an oral formulation of enoximone, entered Phase III clinical trials in mid-year for the treatment of advanced heart failure. Its intravenous formulation of enoximone, Perfan IV for treating heart failure, is sold in Europe.
Jarvik successfully implanted
The first patient with a permanently implanted Jarvik 2000 mechanical heart is still alive, well and back home – more than four months after implantation. The 61-year-old male patient received his Jarvik 2000 left ventricular assist device (LVAD) in June at the John Radcliffe Hospital (Oxford, England), where the Artificial Heart Fund is running clinical trials to assess the suitability of the Jarvik 2000 as a permanent replacement heart for patients in end-stage heart failure. A total of six implants are scheduled over the next few months. In parallel, physicians at the Texas Heart Institute (Houston, Texas) are testing the LVAD device as a bridge to transplant as part of a single-center pilot study. The Jarvik 2000 LVAD has been developed by Robert Jarvik of Jarvik Heart (New York) and Dr. O. Frazier of the Texas Heart Institute.
Like the MicroMed ventricular assist device (VAD) from MicroMed Technology (Houston, Texas), the Jarvik product is an axial flow pump with a multi-bladed impeller shaft spinning at around 10,000 rpm. Although U.S. trials on both pumps are as temporary assists, the two companies see the main long-term application as an alternative to transplants. The Oxford researchers reported that the implanted Jarvik 2000 pump resolved their patient's heart failure symptoms "rapidly." Although it is described by the investigators as "practical and user-friendly," they note that the external batteries need to be recharged every eight hours, with the power connection located at a point on the patient's skull.
The Oxford patient returned home six weeks after the implantation as a result of improvements in heart function, exercise tolerance and kidney function so that diuretic therapy could be withdrawn. Stephen Westaby, senior surgeon on the Radcliffe Hospital team, said there is "great enthusiasm for a mechanical solution for heart failure." He said he feels that the Jarvik product has important advantages over others, primarily because it is mounted inside the left ventricle. He added that this reduces risks both of infection and embolisms.
The Radcliffe team hopes the implanted LVAD will enable the patient's own left ventricle to rest and re-model, with an endpoint of eventual removal of the device. Westaby said that this therapy may work for patients with viral myocarditis and revascularized cardiomyopathy, as well as those with a dilated ventricle. "The device seems to be suitable for permanent use, bridge to transplant or bridge to recovery," Westaby said "The long-term safety and efficacy of the new approach to power delivery (via connections mounted on the skull), and the durability of the pump itself, remains to be proven."
New financing news
Acorn Cardiovascular (St. Paul, Minnesota) reported completing a $24 million private placement of its Series D preferred stock, The funds will support clinical trials for its Cardiac Support Device (CSD), a new therapy for heart failure patients, according to Don Rohrbaugh, Acorn president and CEO. The CSD, a mesh-like device that fits around the heart, is designed to halt the progression of heart failure. Acorn has received CE-mark approval for the CSD in Europe and is conducting a U.S. clinical trial under an FDA-approved investigational device exemption. In June 1999, the company completed a $16.3 million private placement of preferred stock which funded studies in Europe and Australia and the start of the U.S. clinical studies.
Point-of-care blood analysis systems manufacturer Abaxis (Sunnyvale, California) said it completed a private financing raising a total of $5.5 million through issuance of convertible preferred stock that may be converted to common stock at a fixed conversion price of $7 per share. The company said the financing "paves the way for the timely completion of our new manufacturing facility, allowing us to significantly expand capacity and aggressively pursue the market opportunity before us in both the veterinary and medical markets." Abaxis develops, manufactures and markets portable blood chemistry analyzers for use in any patient-care setting to provide clinicians with rapid blood constituent measurements.
LiDCO (London), a developer of hemodynamic monitoring systems, reported receiving a syndicated investment of $3.1 million from the Merlin Biosciences Fund and other existing investors. LiDCO has developed a technology that provides a non-invasive system for measuring cardiac output; it has been approved by the FDA, and the company expects approvals in the UK and Europe next year. It also has developed the PulseCO system approved in Europe.
Hemedex (Cambridge, Massachusetts) reported receiving "a multimillion-dollar equity investment" – the specific amount undisclosed – from Hanmi Pharmaceuticals (Seoul, Korea) to support development of its perfusion quantification technology licensed from Thermal Technologies (Cambridge, Massachusetts). Hemedex develops sensors to measure tissue blood flow, and the company said it will use a minimally invasive probe to develop measurement of perfusion "in absolute units continuously and in real time at the patient bedside or in the operating room." Hemedex said it will establish strategic partnerships in each of the areas targeted for clinical applications of the system.