Medtronic (Minneapolis, Minnesota) and Guidant (Indianapolis, Indiana) last month entered the regulatory ring for another round in their head-to-head battle in the emerging market for implantable devices for the treatment of congestive heart failure (CHF). Separate from all the shouting, St. Jude Medical (St. Paul, Minnesota) quietly made a large advance in the area of pacemaker technology.
In a unanimous vote July 10, the Circulatory Device Systems Panel of the FDA's Center for Devices and Radiological Health (CDRH) recommended approval of Medtronic's InSync Atrial Synchronous Biventricular Pacing Device and Attain Lead System. The InSync device demonstrated statistical significance in its 579-patient study that included 536 successful implants. Unsuccessful implants were associated with an inability to reach a cardiac vein. The panel recommended approval with the condition that Medtronic collect additional data from a six-month trial and 12-month mortality data. "The product improves cardiac function, quality of life, it is safe and it is well-tolerated," William Abraham, director of the heart failure program at the University of Kentucky (Lexington, Kentucky), told the panel on behalf of Medtronic. The company proposes to use the InSync device for patients with advanced heart failure who are New York Heart Association (NYHA) Class III or IV and have a left ventricular ejection fraction < 35% and a QRS > 130 ms. With the panel recommendation, and assuming final approval, Medtronic takes the lead in the emerging $1.1 billion congestive heart failure market, according to analysts.
Earlier on July 10, the FDA panel voted 6-to-2 against recommending approval of Guidant's application for the Contak CD and Easy Trak Lead System. The Contak CD, a combination implantable cardioverter defibrillator (ICD) and biventricular pacing (BVP) device, fell short of meeting statistical endpoints showing that CHF patients who are susceptible to lethal ventricular tachycardias (VT) can benefit from combination therapy. The Contak CD, which had received expedited review from the FDA, was evaluated to determine whether it could broaden the benefits to CHF patients in the mid to late stages of their disease. Begun in 1997, the study followed more than 500 patients to determine if the device could lower a composite measure of CHF and ventricular arrhythmia symptoms by 25% or more, but only a 21% reduction was achieved. According to the company, those results and other positive trends reported in additional trial data, demonstrate that the product helped patients and should have received panel approval with final FDA clearance. Soon after the panel vote, Guidant met with FDA to discuss the next course of action, and early indications seemed promising for eventual approval of the device.
Shortly after, St. Jude received FDA final clearance for its Integrity Afx DR Model 5346 pacemaker, featuring the Dynamic Atrial Overdrive (DAO) algorithm, an algorithm designed to suppress the most common type of cardiac arrhythmia, atrial fibrillation (AF). According to St. Jude, the Afx Model 5346 pacemaker is the first device marketed in the U.S. to offer stimulation therapy that suppresses AF, a problem affecting 5 million people. In the U.S. the condition impacts more than 2 million people, according to estimates, and produces billions of dollars in annual costs. "AFx Suppression serves as a novel, new device-based approach to suppressing AF through 'smart' overdrive stimulation,'" said John Messenger, MD, director of the Heart Institute at Memorial Hospital Long Beach (Long Beach, California).
Approval of the pacemaker was based largely on the ADOPT-A trial (for Atrial Dynamic Overdrive Pacing Trial) results released in May, which showed that delivery of Afx Suppression therapy resulted in a reduction of AF episodes and improvements in quality of life indicators. The technology is designed to control activity in the heart's atrium by continuously monitoring intrinsic atrial activity and stimulating the atrium slightly above the patient's intrinsic rhythm. This serves to suppress two types of AF episodes: brief paroxysmal episodes and longer persistent episodes, and their associated symptoms.
Besides treating AF directly, the device should help to reduce co-morbidities and other serious complications.
Elsewhere in the product pipeline:
Acuson (Seattle, Washington), a Siemens company, said it has added new features to the KinetDx Solutions Network. Key features of the KinetDx Total Viewer system enable physicians and sonographers to automatically transfer cardiac calculations data from the Sequoia Echocardiography system to the KinetDx DS3000 or the CWS3000, eliminating time spent writing up worksheets and improving the turn-around of final reports. According to the company, the system upgrade expands the capabilities in cardiac imaging through the automatic transfer of cardiac calculations data from the Sequoia or Aspen echocardiography systems to the KinetDx worksheet and report package. This will eliminate the time a sonographer spends manually creating worksheets for physicians and will increase the accuracy of final reports. The company said that the system also makes it possible to pre-fetch and view cardiac angiography, computed tomography and magnetic resonance images, which expands the capabilities of KinetDx in both cardiology and general imaging.
Advanced Neuromodulation Systems (ANS; Dallas, Texas) said that the FDA has accepted for review the company's premarket approval application for ANS' Totally Implantable Pulse Generator (IPG) Spinal Cord Stimulator for relief of chronic pain of the trunk and/or limbs. Chris Chavez, president and chief executive officer of ANS, said that on a parallel path, ANS is continuing to seek administrative review of the FDA's Feb. 23 reclassification petition denial letter as a prelude to the company's continuing effort to appeal the denial of its reclassification petition. ANS makes implantable systems used to manage chronic intractable pain and other disorders of the central nervous system.
Ascension Orthopedics (Austin, Texas) received CE mark approval to market its second PyroCarbon implant product, the Ascension PIP, in Europe. Developed to replace the proximal interphalangeal joint of the hand, the implant is produced in four interchangeable sizes, and custom instrumentation is available for achieving a cementless press fit between implant and bone. The implant is designed to allow minimal bone removal, soft tissue preservation and re-establishment of joint function. Ascension makes PyroCarbon orthopedic implants to replace the small skeletal joints of the hand, upper extremity and foot.
Boston Biomedica (West Bridgewater, Massachusetts) received a U.S. patent for its proprietary Pressure Cycling Technology (PCT) for controlling the specificity of nucleic acid (DNA and RNA) hybridization. Patent No. 6,258,534, titled "Pressure Controlled Nucleic Acid Hybridization," describes the use of high pressure to control nucleic acid hybridization, the process that forms the current basis of molecular identification and detection procedures. An important component of these claims is the ability of PCT to provide an alternative approach to current technologies used to control hybridization steps in nucleic acid amplification reactions, such as the polymerase chain reaction, for the detection of low levels of nucleic acids in a sample. Hybridization and amplification methods are used by clinical, diagnostics, pharmaceutical, public health, forensic, agriculture, research, and other laboratories in their studies of infectious diseases, cancer, drug discovery and other important areas. This is the sixth patent issued to the company for the use of PCT. Boston Biomedica provides products and services for the detection and monitoring of infectious diseases such as AIDS and viral hepatitis.
Boston Scientific (Natick, Massachusetts) said it began enrollment in its international TAXUS II drug-eluting stent clinical trial, led by principal investigator Antonio Colombo, MD, of EMO Centro Cuore Colombus (Milan, Italy). The TAXUS program is a series of studies aimed at collecting clinical information on Boston Scientific's paclitaxel drug-eluting stent technology for reducing coronary restenosis. The company said that paclitaxel, the active component of the popular chemotherapeutic agent Taxol, has demonstrated promising results in preclinical studies for reducing the processes leading to restenosis. The stent provides direct delivery of paclitaxel through a polymer at the desired location with a predictable and controlled release. TAXUS II is a 532-patient, multicenter, international study in which patients are randomized to receive either a paclitaxel-eluting stent or a bare, stainless steel control stent, with intravascular ultrasound used to study safety and performance of two separate dose releases of paclitaxel. Boston Scientific has acquired worldwide co-exclusive rights from Angiotech Pharmaceuticals (Vancouver, British Columbia) to use paclitaxel to coat its stent products.
CardioDynamics International (San Diego, California) submitted a 510(k) application to the FDA for its new remote monitoring system, the BioZ dTEL, which uses noninvasive proprietary ICG technology and allows data to be transmitted to physician offices, via the Internet. The DiTEC clinical program is designed to assist nephrologists by enhancing cardiac evaluation and disease management in the dialysis setting, thereby augmenting the overall cardiac care provided. CardioDynamics' primary BioZ Systems use proprietary BioZ Impedance Cardiography technology to noninvasively provide hemodynamic data not previously available in the physician's office and many hospital settings.
Computer Motion (Santa Barbara, California) released the latest version of its Zeus system, using MicroWrist technology. With this new version, the company said, surgeons can employ familiar open surgery movements, while performing endoscopic procedures through tiny 5 mm ports. The 46 Zeus systems currently in use worldwide can be upgraded to the MicroWrist technology. The company expects the majority of its current customers to upgrade, with the anticipated cost to be less than $200,000 per system. According to the company, Zeus with MicroWrist provides a fundamental change in surgeon ease-of-use and system functionality while maintaining the advantages of the Zeus platform. Features of the device include a 5-mm articulating wrist instrument that mimics open-surgery movements in endoscopic procedures; an open platform design that supports integration of complementary technologies such as 3-D visualization and bi-polar/ultrasonic devices; a small system size; and lightweight, modular arms for easy setup, flexible positioning, rapid disassembly and portability. Computer Motion is planning a 3Q01 product launch.
Corgenix Medical (Denver, Colorado) has filed for FDA 510(k) clearance of a test that measures levels of hyaluronic acid (HA) in patients with rheumatoid arthritis (RA). Upon receipt of marketing clearance, Corgenix said it will begin distributing the product worldwide as an aid in the serological evaluation of rheumatic disease with synovial (joint) inflammation, such as RA. According to the company, measurement of hyaluronic acid has other important applications, including liver disease. The company expects to file for additional clinical indications. Corgenix develops specialized diagnostic test kits for vascular diseases and immunological disorders.
CryoCor (San Diego, California) reported expansion of its trial to treat heart arrhythmias with additional procedures being performed by physicians at Academic Hospital Maastricht (Maastricht, the Netherlands). The CryoCor Cardiac Cryoablation System uses intracardiac cryotherapy to treat patients with rapid and irregular heartbeats, including atrial fibrillation. The system delivers refrigerant to the tip of an intravascular catheter. Once positioned inside the heart, the catheter can produce temperatures below -80 degrees Celsius to selectively inactivate the arrhythmia-inducing tissue. The company said that the team of physicians at Academic Hospital Maastricht used the Cardiac Cryoablation System to successfully treat their first patient, a 45-year-old man suffering both atrial fibrillation and atrial flutter. After completing this clinical trial, currently being performed in the Netherlands, Hong Kong and Germany, CryoCor said it will apply for the CE mark for European marketing. The company also plans to submit a request to the FDA that will allow it to conduct similar human clinical trials in the U.S.
Cybernet Medical (Ann Arbor, Michigan) said that the MedStar interface device and accompanying collection server, together called the MedStar System, for improving in-home patient chronic disease management is now available. The MedStar device collects outpatient physiological data from multiple off-the-shelf instruments, such as blood pressure cuffs and weight scales. It then securely transmits the data over a standard phone line to the Cybernet Medical collection server, located at a disease management company's facility, for retrieval and analysis. This process enables a health care team to immediately note changes in a patient's condition and make appropriate action recommendations, according to the company. The device connects directly to the off-the-shelf collection instruments that a chronic care patient typically has at home. Instead of using a modem that would drain the batteries after a single transmission, it uses a proprietary dialing protocol to transmit digitized data over standard telephone lines to the Cybernet collection server.
Cyberonics (Houston, Texas) reported that the 235th and final patient received an implant of the NeuroCybernetic Prosthesis (NCP) System as part of an expanded U.S. Phase III study of vagus nerve stimulation (VNS) for chronic or recurrent depression. In June, Cyberonics received FDA approval to expand the original study protocol from 210 to up to 240 patients. The NCP System is an implantable medical device similar to a cardiac pacemaker that delivers mild electrical stimulation to the left vagus nerve in the patient's neck. Implantation of the stimulation generator and electrode is typically done on an outpatient basis in about one hour. Mechanism of action studies suggest that VNS modulates activity in the areas of the brain responsible for mood, motivation, sleep, appetite and alertness, Cyberonics says. In the randomized, double blind, placebo-controlled study, 235 patients were implanted, but neither investigators nor patients will know if the systems are activated until completion of the trial and release of the preliminary results.
FzioMed (San Luis Obispo, California) reported being granted CE mark certification for its Oxiplex adhesion barrier technology for use in spine, abdominal and pelvic surgery. Oxiplex/SP Gel and Oxiplex Film are bioabsorbable adhesion barriers designed to reduce post-surgical adhesions. The company said that Oxiplex/SP Gel is only the second bioabsorbable adhesion barrier product to receive CE Mark for use in spine surgery. FzioMed's products in development using Oxiplex include those for the prevention of post-surgical adhesions, hemostasis during surgery, osteoarthritis and drug delivery.
Guidant (Indianapolis, Minnesota) received FDA clearance to market its newest stent system, the Omnilink .035. The Omnilink .035 Biliary Stent System is intended for the treatment of malignant biliary obstructions, blockages that form in ducts that carry fluids from the liver to the gallbladder or from the gallbladder to the small intestine. The system is compatible with a .035-inch guide wire, and is Guidant's first offering of a stent system designed for use with a slightly larger diameter .035-inch guide wire. The Omnilink .018 System, which received FDA clearance recently, features the same Omnilink stent mounted on a delivery system designed for use with a thinner .018-inch guide wire. Guidant offers the Omnilink .035 system with two diameter-specific stents for different sized blockages. The smaller .035 stent has inner diameters of 5 mm to 7 mm and the larger has inner diameters of 8 mm to 10 mm. A key feature of the Omnilink .035 system is a thinner Xcelon balloon material designed to give the delivery system a lower profile enabling a smaller puncture site. This system builds on the company's Megalink SDS Biliary Stent System design and was developed to improve navigation through anatomy and the ability to access blockages, according to Guidant.
HomMed (Brookfield, Wisconsin) has introduced the Sentry III, the third generation of its monitoring system. Sentry III is the only base unit of its kind capable of simultaneously interfacing with multiple peripherals to guide patients through seamless vital sign retrieval, HomMed said. This design feature eliminates the need to plug and unplug individual peripherals to acquire certain vital signs, a process required by competitive systems and often difficult for patients to follow, according to the company. The system allows patients to use standard vital sign measurement tools to gather heart rate, blood pressure, blood oxygen saturation and body weight and temperature information, and combine them with one or more of four new peripheral components such as a spirometer, blood glucose meter, PT/INR and optional video conferencing capability. The system is capable of collecting all data in just three minutes, or about half the time of other systems, according to the company.
Integra NeuroSciences, the neurosurgical division of Integra LifeSciences Holdings (Plainsboro, New Jersey), reported receiving 510(k) clearance from the FDA for its NeuraGen Nerve Guide, an implant for the repair of severed peripheral nerves in the extremities. Peripheral nerves may become severed through traumatic accidents or surgical injuries, often resulting in the permanent loss of motor and sensory function. The device is an absorbable collagen tube providing a protective environment for the regenerating nerve and also providing a conduit through which regenerating axons can bridge the injury. The technology is based on a semi-permeable collagen tube that isolates and defines an environment for the extension of axons and growth of Schwann cells, the elements responsible for functional recovery following nerve injury. The company said it would launch the NeuraGen in the U.S. in 4Q01. Additionally, the company plans a submission for CE mark certification and is working with its strategic partner, Century Medical, to obtain market approval in Japan. Integra makes implants, devices and monitors used in neurosurgery, neurotrauma, and related critical care.
Jomed NV (Ulestraten, the Netherlands) a developer of products for minimally invasive vascular intervention said that the FOX, a PTA catheter, has been cleared for marketing in the U.S. PTA catheters are used to open up non-coronary arteries and place stents in a minimally invasive fashion. Jomed said it expects to launch the FOX in the U.S. market toward the end of the year.
Kendall (Mansfield, Massachusetts), a business unit of Tyco Healthcare, launched the Goldenberg Snarecoil Bone Marrow Biopsy Needle. The needle incorporates a patented internal mechanism eliminating the need to rock or twist the needle when severing the specimen. According to the company, this helps clinicians quickly and precisely harvest long non-fragmented bone marrow samples. The internal sampling mechanism is activated with an on/off lever and allows for specimen capture without redirection of the needle. This results in greater patient comfort during marrow harvest and greater specimen integrity, according to Kendall. The trocar tip stylet is designed to protect the needle during insertion, ensuring needle sharpness. The needle is available in both procedural trays and single needles. Kendall makes wound care, needles and syringes, vascular therapy, urological care, incontinence care, sharps disposal and nursing care products.
MedAmicus (Plymouth, Minnesota) has received FDA 510(k) clearance for its center-line retractable Guidewire Introducer Safety Needle, a product licensed from and co-developed with Med-Design (Ventura, California). The company said it expects market launch of the product in 3Q01. MedAmicus makes percutaneous delivery systems, while Med-Design develops safety needle devices for blood collection, infusion therapy, insertion and injection.
Milestone Scientific (Livingston, New Jersey) has received FDA marketing clearance for The Wand Plus computer-controlled anesthetic delivery system. Contemplated uses include the injection of lidocaine subcutaneously or intramuscularly for infiltration and nerve block. Milestone said the clearance comes on the heels of favorable clinical studies in podiatry and colorectal surgery.
Nastech Pharmaceutical (Happauge, New York) filed a premarket notification 510 (k) application with the FDA for marketing clearance for its Mammary Aspiration Specimen Cytology Test (MASCT), a non-invasive, non-powered device that draws nipple aspirate fluid (NAF) from the breast for cytological examination. It is being developed as an adjunct to current medical care, including mammography and clinical breast exams, and arises from the company's acquisition of Atossa HealthCare in August 2000. Nastech recently released results from a clinical trial showing that the device provides clinically useful mammary aspiration specimens for cytological examination that may prove useful in the diagnosis of breast cancer. Nastech anticipates that a successful breast aspirator device for cytological evaluation may provide adjunct diagnostic information for the early detection of breast cancer, similar to the way a Pap smear provides diagnostic information for the early detection of cervical cancer.
Pheromone Sciences (Toronto, Ontario) said it is in the process of completing the formal submission for regulatory approval for its PSC Fertility Monitor in Europe. The submission, which the company said it expects to complete this month, will provide for CE mark registration. The PSC Fertility Monitor is designed to give women advance notice of their peak fertility and ovulation days. The fertility monitor is housed in a modern styled wristwatch like device with a LCD readout and is worn at night while asleep. It is a noninvasive device that predicts ovulation by measuring ion changes on the surface of the skin. The device incorporates an interactive microprocessor combined with a biosensor enabling it to take up to 12 daily measurements from the skin surface and to evaluate the data in order to predict the status of the user, with four days advance notice, as being not-fertile, fertile or ovulating. Results can be viewed at any time on the LCD screen of the device or as a computer-generated graphical printout for medical professionals.
Quidel (San Diego, California) received U.S. Patent No. 6,251,621 for its Reporter Enzyme Release technology. The patent covers the use of the Quidel LTF (Layered Thin Film) technology to detect a group of enzymes called hydrolases and their inhibitors. Hydrolases are enzymes produced by infectious agents including bacteria, viruses, protozoa and yeast that can serve as important virulence factors for these pathogens. Hydrolases can also be present in bodily fluids as a result of diseases such as cancer and hepatitis. The patent also covers systems for detecting hydrolase inhibitors.
Response Biomedical (Vancouver, British Columbia) has filed regulatory submissions with the FDA and the Canadian Therapeutic Products Directorate for market clearance of both its RAMP Reader and the first RAMP whole blood test. The RAMP System is designed to deliver laboratory comparable results in 10 minutes. The first test for which Response is seeking clearance is for myoglobin, a cardiac marker that is measured to assist in the diagnosis of a heart attack. The company said that testing with RAMP could provide doctors with the information needed to diagnose and treat heart attack patients before irreversible heart damage or death occurs. Rapid diagnosis reduces costs associated with unnecessary hospital admissions. RAMP also can aid in reducing the number of patients who are undiagnosed and have subsequent heart attacks, according to the company. It said that studies have shown that myoglobin levels are elevated quickly after a heart attack. In addition to myoglobin, tests are being developed by Response for two other common cardiac markers: CK-MB and troponin I. As a group, these markers are effective as aids in the diagnosis of heart attacks, provided that test results are received in a timely manner.
St. Jude Medical (St. Paul, Minnesota) reported that Evanston Northwestern Healthcare (Evanston, Illinois) was the first center in Illinois to perform open-heart surgery using a connecting technology that replaces the traditional suture in the procedure. The FDA approved the new device, the St. Jude Medical Symmetry Bypass System Aortic Connector, in May, and since June 1, surgeons have used the aortic connector in 15 coronary artery bypass graft procedures. The connector enables Evanston Northwestern Healthcare heart surgeons to perform a minimally invasive, "no touch" coronary bypass graft surgery on a beating heart. The new aortic connector allows surgeons to attach vein grafts to the aorta with a star-shaped rivet, a mechanical procedure taking less than 10 seconds vs. three to five minutes to sew the connection by hand.
STAAR Surgical (Monrovia, California) reported that Health Canada issued a medical device license for its Implantable Contact Lens (ICL), clearing the way for the company to begin marketing and distribution of the product in that country. Health Canada gave wide-ranging approval of the ICL for use in hyperopic (farsighted) eyes from +3.0 diopters to +20.0 diopters and for use in myopic (nearsighted) eyes from -6.0 diopters to -20.0 diopters. David Bailey, STAAR's president and CEO, said, "This is the first approval of the ICL or any phakic implant in North America and it has come even earlier than anticipated. We believe the potential of the Canadian refractive market will exceed $600 million, with the eventual U.S. market potential exceeding $6 billion." Bailey said that a good portion of the data reviewed by Health Canada was from the U.S. clinical trials. ICL is a surgically implanted lens that uses optical concepts similar to contact lenses or glasses to achieve vision correction. The optic of the lens is customized to address each patient's refractive error. Surgeons implant the ICL in front of the human lens in a matter of minutes. Unlike laser refractive correction, the ICL makes no permanent change in the structures of the eye and the procedure is reversible. STAAR Surgical develops medical devices for use in refractive, cataract and glaucoma surgery.
TherMatrx (Chicago, Illinois) received FDA clearance to begin marketing its TMx-2000 transurethral microwave thermotherapy system for treating benign prostatic hyperplasia. The Health Care Financing Administration (Baltimore, Maryland) has already granted substantial reimbursement for transurethral microwave thermotherapy, making it possible for TherMatrx to quickly enter the market using a direct sales force already in place. TherMatrx patents are licensed by Urologix for its Targis and Prostatron systems.