Guiding a catheter or guidewire through the human vasculature and then manipulating its distal end at a targeted site is a far cry from traditional surgery. Rather than up close and hands-on, such procedures are like trying to thread a needle – with the needle and thread somewhere four feet distant from your hand, says Bevil Hogg, president and chief executive officer of Stereotaxis (St. Louis, Missouri).
Or in another analogy, he offers: "Think of a very, very wet noodle." Try placing the other end of the noodle at a specific point, and "You don't get very good results," Hogg told BBI.
But that is very much the job given to clinicians in the cath lab or interventional suite and a task that will be made much easier, he predicts, with the Stereotaxis Magnetic Navigation System. The system was used recently in the first procedure launching a clinical trial approved under the FDA's investigational device exemption (IDE) protocol to direct a guidewire through the vasculature and to the heart of a 40-year-old woman to treat a cardiac arrhythmia. The procedure was described by the company as the first use of computer-controlled robotics as a catheter guidance system in this time of cardiac procedure.
Thus far, the purpose of the IDE study is fairly limited: exploring only whether the guidewire could be accurately and safely delivered, via robotic guidance, to the target area in the heart, says Hogg. But this is just the first step in its use to deliver catheters and guidewires to various parts of the body for complex treatments.
The cath lab is a perfect venue for the system, since this area of the hospital is "a pretty technology-rich environment," according to Hogg. "The cath lab incorporates a significant amount of diagnostic imaging information, from X-ray to fluoro, and incorporating various software enhancements of imaging and oftentimes with preoperative road mapping and other diagnostic tools for planning a procedure."
But this wealth of information, besides offering various opportunities, Hogg says, presents a problem. "All of this information is processed by the physician himself or herself. They are expected to be able to perform some very torturous and delicate procedures, manipulating catheters and guidewires to be able to access target sites." He adds, "It's a challenge in training and dexterity and the length of the procedures. Then there is the overall burden to deliver ever-increasing degrees of sophistication in terms of medical devices to remote sites and do it in a cost-effective fashion."
The magnetic field of the Stereotaxis system essentially provides control of the catheter tip, while at the same time using the information available in the cath lab for enhanced guidance, Hogg says. "The magnetic field controls the front end of the catheter, since it can project a force at a distance," he adds. "We've taken manually operated catheters and guidewires and turned them into digitally controlled instruments with a tremendous amount of dexterity."
Hogg says that, once approved, other advanced uses of the system will be driven by the increasing demand for minimally invasive procedures and the movement of more and more complex procedures to endovascular approaches in the interventional suite.
The current trial in cardiology will include 20 patients in St. Louis and additional procedures at the University of Oklahoma.
Besides laying the foundation for simpler ways to deliver ablation to treat cardiac arrythmias, the system late last year also was used in an IDE trial to navigate a catheter into the brain. A procedure such as this provides the first step in evaluating the system for performing less-invasive biopsies of suspected brain tumors or in treating aneurysms.
Elsewhere in the product pipeline:
A new study just published in the Journal of the American College of Cardiology confirms the importance of a new, rapid test for congestive heart failure (CHF). The Triage BNP Test from Biosite Diagnostics (San Diego, California) is used to diagnose CHF in hospital emergency rooms. Within 15 minutes the device measures levels of a hormone called BNP that is elevated in patients with CHF. The first FDA-approved diagnostic test for CHF can now aid a physician in quickly assessing a patient's status – therefore, according to the company, eliminating the need to wait hours for tests to come back.
CardioTech (Woburn, Massachusetts) received a U.S. patent titled "Functionalized Polyurethanes." This patent relates to polyurethanes containing a negative surface charge due to the presence of carboxylic acid groups on the molecular chain. The presence of negative charges allow the polyurethanes to be used as coatings for controlled delivery systems of drugs, enzymes and other pharmacologically active agents. Dr. Murray Reich, the senior inventor, said, "These polyurethanes should find applications in coatings for stents, vascular grafts and other chronic implantable devices. The ability to deliver pharmacologically-active agents may be important in preventing coagulation, infections and restenosis."
Conceptus (San Carlos, California) said it has received CE-mark approval to market its STOP (Selective Tubal Occlusion Procedure) device, a non-surgical alternative for women considering tubal ligation. The company estimates that there are more than 10 million women in the European Union who are potential candidates for this procedure. STOP is indicated for occluding the fallopian tubes for permanent contraception. STOP is already listed for sale with the Therapeutic Goods Administration in Australia, with a reimbursement code comparable to surgical tubal ligation. The company plans commercial introduction of STOP in Australia 1Q01. In the U.S., Conceptus was recently issued a patent for its STOP technology. Last month, enrollment concluded for a pivotal clinical study leading to a planned premarket approval filing with the FDA during 3Q02.
Consortium Service Management Group (CSMG; Corpus Christi, Texas) said that the company, through its Ukraine partners, International Association Welding (IAW) and the E.O. Paton Institute of Electric Welding at the National Academy of Sciences of Ukraine, has received permission and certification from the Ukraine Ministry of Health for marketing and distribution of its platform medical device technology for bonding of live biological soft tissue. The device bonds living soft biological tissue without the use of foreign matters or conventional wound closing devices such as sutures, staples, sealant or glues. Unlike other RF tissue coagulation methods that tend to destroy tissue by charring, searing and necrosis, the CSMG platform technology bonds together incised tissue and avoids charring, searing and necrosis using a low heat delivery method aimed at restoration of the normal functions of the live organ and tissue. The method has been successfully used in gynecology, gall bladder, liver resection, large and small intestine repair, fallopian tube repair, nerves and skin, as well as other tissues and organs. U.S. and international patents are pending.
Cordis (Miami Lakes, Florida) said it received permission from the FDA to commence a randomized pivotal clinical study in the U.S. of its new Sirolimus pharmaceutical-coated Bx Velocity Coronary Stent. Known as the SIRIUS Study, the pivotal U.S. clinical study is designed to enroll 1,100 patients. The FDA's conditional approval for enrollment of patients in this trial requires Cordis to provide some additional information from ongoing studies. The company anticipates it will fully satisfy the conditions within the time period set forth by the FDA. The company says that this is the first pharmacologic coating to be developed and studied on stents as an advanced treatment for coronary artery disease. Cordis is a Johnson & Johnson company.
CryoLife (Kennesaw, Georgia), a developer of tissue-engineered implantable heart valves, vascular grafts and protein-based surgical adhesives, said that the Australian Therapeutic Goods Administration has issued a certificate of registration for BioGlue Surgical Adhesive. This approval allows the commercial distribution of BioGlue Surgical Adhesive in Australia. BioGlue has been approved for vascular and pulmonary repair in 41 countries worldwide and is commercially available in the U.S. under an FDA-approved humanitarian device exemption for use as an adjunct in the repair of acute thoracic dissections, a life-threatening condition. More recently, the company filed a premarket approval application for the use of BioGlue in vascular and cardiac repair.
CytoLogix (Cambridge, Massachusetts), a maker of cellular and tissue analysis technologies, has been awarded a U.S. patent titled "Random Access Slide Stainer With Independent Slide Heating Regulation." This is the second recently issued patent covering CytoLogix' proprietary technology for fine temperature regulation of biological samples mounted on microscope slides. CytoLogix recently was awarded a patent titled "Moving Platform Slide Stainer With Heating Elements." The two patents cover an enabling technology for many types of automated tests for the clinical, research, genomics and drug discovery markets. The newly patented technology is incorporated into the company's Artisan instrument system, an instrument capable of automating both special stains and immunohistochemistry, according to the company. With this technology, the system can simultaneously perform different test procedures that require distinct temperatures. The technology is particularly important for slide-mounted samples, such as cells or tissue sections for cancer diagnosis, functional genomics research, and gene and protein arrays for drug discovery applications.
Digene (Gaithersburg, Maryland) said it has received expanded funding for its Phase II Small Business Innovation Research contract from the National Institute of Allergy and Infectious Diseases to develop a new generation of tests for the diagnosis of herpes simplex virus (HSV). The initial Phase II contract, which was awarded in June 1998, was for $750,000. The contract expansion represents approximately $320,000 of incremental funding. The HSV tests that Digene plans to develop are expected to address a global clinical market underserved by existing diagnostic tests. Digene will apply its Hybrid Capture technology, capable of ultra-sensitive, high throughput DNA diagnostic testing, to improve detection, screening and monitoring of patients with HSV types 1 and 2 infection. Digene makes DNA and RNA testing systems for the screening, monitoring and diagnosis of human diseases. The company has developed and is commercializing its Hybrid Capture system and tests in three areas: women's cancers and infectious diseases, blood viruses, and genomics and pharmaceutical research. Digene's lead product is the only FDA-approved test for human papillomavirus, or HPV, which is the cause of greater than 99% of cervical cancer cases. The Digene HPV Test is used in the U.S. as an adjunct to the Pap smear for cervical cancer screening and is being marketed in selected countries as a primary cervical cancer screen either in conjunction with or separate from the Pap smear.
EchoCath (Princeton, New Jersey) said it plans to market a portable version of its EchoFlow system to measure blood velocity. The EchoFlow device has been the subject of clinical evaluations in 12 medical centers in the U.S., with major interest in its use for dialysis-access-graft surveillance and intra-operative vessel assessment. President Frank DeBernardis said, "Our clinical investigators asked for a portable version of the operating-room system, one they could carry with them. Our engineers responded by shrinking the system from 70 pounds to two pounds, putting the key functions of the research-oriented system in a hand-held box." He said the new system is set for shipment this spring. DeBernardis also reported that the company has been granted a fifth patent on its diffraction-grating technology used in EchoFlow systems. "This patent, No. 6,176,829, 'Multi-Beam Diffraction Grating Imager Apparatus and Method,' shows how to use our technology to produce real-time, three-dimensional imaging; we will continue to explore this and other technological expansions of our technology."
ELA Medical (Paris), a cardiac rhythm management company, reported that the first three European implants of its new, small, dual-chamber implantable defibrillator, the Alto DR, had taken place. This new device includes the PARAD/PARAD+ (P- and R-based Arrhythmia Detection) algorithm that the company says reduces the number of inappropriate therapies. This was the device used in the Slow Ventricular Tachycardia (VT) Study, an international multicenter randomized trial sponsored by the company. This protocol is designed to determine the incidence and evolution of slow VT, as well as the concomitant clinical and psychological impact on patients.
Encore Medical (Austin, Texas) said that its subsidiary, Encore Orthopedics, has made a new hip implant available to orthopedic surgeons that will aid in eliminating polyethylene wear, one of the major causes of implant loosening. This new product is a metal insert that replaces the traditional polyethylene inserts that mate with a metal femoral head. This product introduction comes as a result of completing a clinical study and receiving clearance from the FDA to begin commercial distribution. The new insert is used with the Encore FMP Acetabular Shell and any of the company's hip stems. Encore Orthopedics said it becomes one of only a few companies in the industry to have this product offering. In addition to this metal/metal hip, Encore's development program in alternative bearings includes a current IDE study for a ceramic/ceramic hip articulation and a project for a ceramic knee femoral component. Encore makes orthopedic total joint, trauma and spinal implants.
Enterix (Falmouth, Maine) said that its new colorectal cancer screening test, !nSure, has received premarket clearance from the FDA. !nSure is an immunochemical fecal occult blood test (FOBT) that detects hidden (occult) blood that originates in the lower intestine, which might indicate a developing cancer. The new test was designed to address the compliance-limiting deficiencies associated with existing FOBTs, most of which are based on 30-year-old technology. Clinical trials show that !nSure is highly sensitive and specific for the detection of colorectal cancer and pre-cancerous adenomas. In sensitivity trials, !nSure detected 87% of cancers and 47% of pre-cancerous polyps. In laboratory studies conducted by academic researchers, the company said that !nSure was shown to have tenfold greater sensitivity than the leading competitor. !nSure showed a specificity of 98% in three separate clinical studies.
FzioMed (San Luis Obispo, California) said it has initiated a clinical trial of its Oxiplex/SP spine surgery product. The FDA recently approved FzioMed's investigational device exemption application to conduct a multicenter clinical study of the new product. Oxiplex/SP is a bioresorbable material that is applied within the surgical site during lumbar surgery and is designed to reduce post-operative peridural scarring, also known as post-surgical adhesions. Post-surgical adhesions are a leading complication of many surgical procedures. Ronald Haynes, president and chief executive officer of FzioMed, said, "The start of this, our second Oxiplex clinical trial, is a key milestone in expanding the market potential for FzioMed technology. There is a great unmet need for an effective anti-adhesion product in spine surgery, and we believe that Oxiplex/SP can be an important tool for surgeons."
Guidant (Indianapolis, Indiana) reported what it termed "promising results" from a series of preclinical studies with its Pharma-Link Stent System Program. The company said preliminary angiographic and intravascular ultrasound results demonstrated a marked reduction in the growth of cells at the site of the drug eluting stent in comparison to stent placement without a drug. In addition, histologic data indicated a significant reduction in hyperplasia (the re-growth of cells at the treated site) as compared to the control stent. The addition of a therapeutic agent to stents is being developed as a means of reducing restenosis, the longer-term re-growth that can block a treated artery. Guidant's Pharma-Link program offers drug-eluting capability on the company's latest stent platform. Developed to be a complete system for treating coronary blockages, the stent system includes a proprietary coating consisting of a timed-release polymer containing Actinomycin D, an antineoplastic drug developed by Merck & Co. Guidant's drug-eluting stent system is in the research and development phase and the company said it expects to begin human clinical studies with this stent in 2Q01.
Harvest Technologies (Plymouth, Massachusetts) said it has received its second FDA concurrence on its SmartPReP PRP System. The SmartPReP is designed for the safe and rapid preparation of autologous platelet rich plasma from a small sample of blood at the patient's point of care. The PRP can be mixed with autograft or allograft bone grafting material prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements. The process makes available PRP for mixing with bone grafting materials for delivery to the intended site using a bone graft delivery syringe or other suitable mixing containers (e.g. bone grafting material mixing cup). The platelet rich plasma may improve the handling characteristics of the bone graft material, facilitate fixation of the bone graft material to the intended surgical site and may help to optimize conditions for bone healing. The Harvest FDA concurrence is the first issued for any clinical PRP indication, says the company. The SmartPReP System provides a process to prepare PRP at the patient's point of care, using only a small sample of the patient's blood (approximately 50cc). The entire process is completely automated and takes less than 15 minutes. Gary Tureski, Harvest's president, said, "We see PRP eventually being utilized in a multitude of surgical procedures as a natural, safe autologous biologic." Harvest believes this FDA concurrence will also significantly aid its strategic partner DePuy Orthopedic (Warsaw, Indiana), a Johnson & Johnson subsidiary, in its entry in the orthopedic biomaterials market. DePuy markets the Harvest SmartPReP under the Symphony label to the orthopedic markets in the U.S. and has an option for international markets.
International Medical Innovations (IMI; Toronto, Ontario) said that it has received a medical device license for its skin cholesterol test, Cholesterol 1,2,3, by the Therapeutic Products Programme (TPP) at Health Canada. The license allows IMI to market and sell Cholesterol 1,2,3 in Canada for risk assessment of coronary artery disease. This is the first license granted for a noninvasive cholesterol test in Canada, according to the company. The test measures cholesterol in the skin without requiring a blood sample. The test takes three minutes and reads a color change in a drop of liquid on the palm of the hand, using a hand-held spectrophotometer developed by X-Rite (Grand Rapids, Michigan). It is now cleared for use by health professionals and is designed for use in physicians' offices, pharmacies, clinics and laboratories. A home version of the test is in development. IMI makes products for the early detection of life-threatening diseases, particularly cardiovascular disease and cancer.
Light Force Therapy said that Health Canada has given the company clearance to market its two flagship products for human use in Canada. The newly redesigned Acubeam and Super Nova units will be sold throughout Canada for pain relief in humans, as it already is in the U.S.
MetaMetrix (Norcross, Georgia) recently made available its new QuikStiX fingerstick food allergy test. The test does not require venipuncture but only needs a few small drops of blood from a simple stick of the finger. Health practitioners who do not usually draw blood, like pharmacists, chiropractors and naturopathic doctors, can use this test to reveal their patients' delayed, or "hidden", food allergies, the most common form of adverse food reaction. The company says that the test is so easy to use that patients can do it at home. The test kit includes illustrated instructions, two disposable lancets, a sample collection card and return mail packaging to ensure prompt turnaround time for the results. The new test measures the IgG immune response to 10 of the most common foods (egg, wheat, milk, corn, soy, rice, mustard, salmon, tuna, and beef) and two types of mold (penicillium and aspergillus) commonly found in many processed foods. High levels of IgG to a food can cause symptoms up to seven days after the food is eaten. Therefore, symptoms may be delayed and chronic, and people with IgG food allergies may not associate consumption of offending foods with the way they are feeling. Along with the test results, MetaMetrix provides an information packet that includes an interpretive guide, a list of food families to avoid, dietary recommendations and a list of resources. MetaMetrix Clinical Laboratory offers nutritional, metabolic and toxicity testing and services to health care providers for identifying nutritional influences on health and disease.
Novartis Ophthalmics (Duluth, Georgia), the eye health unit of Novartis (Basel Switzerland), and QLT (Vancouver, British Columbia) said that recent results of a study showed that Visudyne therapy reduces the risk of vision loss in a new population of patients with wet age-related macular degeneration (AMD). The results were from a multicenter phase IIIb randomized placebo-controlled study, called the VIP (Verteporfin In Photodynamic therapy) trial, in which most patients had lesions composed of occult subfoveal choroidal neovascularization (CNV) without classic components. Visudyne is currently approved for the treatment of patients with predominantly classic subfoveal CNV caused by AMD, the leading cause of severe vision loss in people over the age of 50. In addition, the results also confirmed the benefits of Visudyne therapy at 24 months in the treatment of CNV due to pathologic myopia, for which regulatory approval is pending in North America and Europe. The most frequently reported adverse events attributed to the treatment were injection site events and visual disturbances. Visudyne therapy is a two-step procedure that can be performed in a doctor's office. First, Visudyne is injected intravenously into the patient's arm. A non-thermal laser light is then shone into the patient's eye to activate the drug. Visudyne therapy uses a specially designed laser that produces the low level, non-thermal 689nm light required to activate the drug. The therapy is being co-developed for various ocular conditions by Novartis Ophthalmics and QLT. Novartis Ophthalmics markets the product worldwide, while QLT is responsible for manufacturing.
Orthovita (Malvern, Pennsylvania), a developer of orthopedic biomaterials, released the results of key assessment of its VITOSS Synthetic Cancellous Bone Void Filler product. In this test, the Urist pouch test, VITOSS mixed with bone marrow aspirate (BMA) was compared to the leading demineralized bone matrix (DBM) human cadaver allograft. According to David Joseph, Orthovita chairman, "VITOSS mixed with BMA exhibited a faster rate of bone formation, with more consistent bone formation throughout the graft material at 2, 4 and 8 weeks when compared to the leading DBM. VITOSS mixed with BMA yielded significantly better bone architecture and maturity at each time point when compared to the leading DBM. These data will be published later in the year and will be presented at coming orthopedic meetings." VITOSS is the first engineered 90% porous beta-tricalcium phosphate synthetic cancellous bone void filler FDA-cleared for use in the spine, extremities and pelvis, says the company.
Prevent Products (West St. Paul, Minnesota) said that it has received a 510(k) approval from the FDA for its Phlebopump Model 1000. The Phlebopump Model 1000 is intended to enhance circulation in the lower leg.
Quidel (San Diego, California) has launched the Metra Helical Peptide immunoassay, a urine test for measuring the breakdown of collagen. This assay for a new biochemical bone marker expands Quidel's portfolio of bone health products. It was initially intended for use by researchers seeking to characterize the degradation of bone tissue that occurs in osteoporosis and related diseases, and in detecting the effects of therapies that halt such destruction. A U.S. patent protects the assay and the peptide it measures, and additional patents are pending. Quidel makes point-of-care, rapid diagnostics for detection of medical conditions and illnesses.
Somanetics (Troy, Michigan) said that the results of a clinical study and a workshop on regional low flow perfusion cardiopulmonary bypass, a new bypass management technique for infants undergoing congenital malformation repair surgery, and the use of cerebral oximetry to monitor blood oxygen levels during the surgery were presented during the Society of Thoracic Surgeons annual meeting in New Orleans. The regional low flow perfusion technique was developed as an alternative to the need for long periods of deep hypothermic circulatory arrest because of the potential neurologic damage of such surgery to the babies undergoing the surgery. It reduces the need for extreme cooling and complete circulatory arrest by providing continuous cerebral circulatory support during the open-heart surgery, the company said. The study used Somanetics' Invos Cerebral Oximeter. The company says that the Invos is the only patient monitoring system commercially available in the U.S. that non-invasively and continuously monitors changes in the regional oxygen saturation of the blood in the adult brain. Somanetics recently obtained FDA 510(k) clearance for the Invos 5100 Cerebral Oximeter, which has the added capability to monitor pediatric patients.
Smith & Nephew (Memphis, Tennessee) said the VersaBond medium-viscosity bone cement distributed by its Orthopedics Division has received clearance from the FDA under its premarket notification 510(k) process. VersaBond was to go on sale in late February. Smith & Nephew said it is the first company to receive marketing clearance for a bone cement under the 510(k) process since they were reclassified from Class III to Class II devices under FDA guidelines. Manufactured by Coripharm Medizinprodukte GmbH & Co. in Germany, VersaBond uses chemistry similar to that found in other leading cements on the market, but has improved mechanical properties over many competitive cement products, and has superior fatigue strength. VersaBond can be used in shoulder, hip and knee replacement procedures and can be injected or hand packed into place.
Spectranetics (Colorado Springs, Colorado) said it has received approval from the FDA to begin Phase II of the Laser Angioplasty for Critical Limb Ischemia (LACI) trial, which is intended to demonstrate the safety and effectiveness of Spectranetics' laser angioplasty technology to treat blockages in arteries of the leg, primarily at or below the knee. The company will begin the Phase II trial immediately and enrollment is expected to take 12 to 15 months to complete. Spectranetics anticipates submitting a request to the FDA for approval to market this application in mid-to-late 2002. The company already has CE mark approval in Europe for this application.