Micro Therapeutics (MTI; Irvine, California) has received CE mark approval for yet another use of its Onyx Liquid Embolic System (LES) – treatment of brain tumors. George Wallace, MTI's president and CEO, told The BBI Newsletter, "What we are trying to do in the case of head and neck tumors is shut off blood from the areas we don't want it, thus allowing a surgical resection to be virtually bloodless in this very delicate area of the brain." The Onyx system is used as an adjunct to brain surgery, and the embolization process takes place one to two days prior to the surgery. Onyx was approved in May 1999 for use in peripheral vascular applications and arteriovenous malformations (AVMs) of the brain last July. It also is compatible with for use with radiosurgery, a noninvasive treatment that uses gamma rays to shrink brain AVMs.

Onyx is a black liquid embolic material that is positioned and released into vascular defects via micro catheters. Once deployed, the material quickly transforms into a solid, but flexible, polymer mass. Wallace called the product "a polymer dissolved in liquid." It can be selectively positioned to either stop or restore blood flow, depending on a patient's needs. MTI also holds patents to the delivery devices for the product, which require special plastics that prohibit clumping in the catheters. "Onyx is a spongy mass, and can be clamped, making it popular with surgeons," Wallace said, adding that "we have the potential to treat AVMs in all parts of the body."

MTI was founded in 1993, and its product is gaining acceptance in Europe. Wallace sees FDA approval as still some time away, however. "We still must complete IDE [investigational device exemption] studies," he said. "I think we will be able to gain FDA approval for peripheral vascular applications by the fourth quarter of 2001, since we will have the most European data to present to them on this application. We probably will have approval for most other applications by 2002." He said MTI is working on other indications for Onyx, including ovarian vein seals, and abdominal aneurysms. Guidant (Indianapolis, Indiana) will be MTI's partner in the European Union, responsible for distribution of Onyx and MTI's line of micro catheter, access, and delivery products.

Elsewhere in the product pipeline:

ADAC Laboratories (Milpitas, California) has received FDA 510(k) clearance to begin marketing Skylight, the first gantry-free nuclear medicine gamma camera. Skylight, introduced by ADAC at the 1999 Radiological Society of North America conference, provides openness and imaging flexibility, according to the company. The system is based on an architecture that allows gamma detectors to be mounted directly into a room structure, thus removing limits associated with the floor-based mechanical gantries of existing nuclear medicine gamma cameras. This opens "a number of potential expansions in the field of nuclear medicine," according to ADAC. These include the combination of nuclear medicine with other diagnostic imaging modalities such as computed tomography and ultrasound, and the use of nuclear imaging in surgical and interventional applications.

Biosyntech (Montreal, Canada) introduced the Arthro-BST, an arthroscopic probe used for the diagnosis of arthritis, at the recent 3rd Symposium of the International Cartilage Repair Society in Goteborg, Sweden. Michael Buschmann, PhD, vice president, research and development, said the instrument provides "an objective, quantitative functional evaluation of cartilage and the arthroscopic procedure presents the benefits of being minimally invasive and rapid." The Arthro-BST uses an array of microelectrodes to measure streaming potentials during the compression of the cartilage. It has no moving parts, is easy to make and sterilize, and requires no special training to use, according to Biosyntech. Besides making medical instruments for the evaluation of cartilage repair and diagnosis in arthritis, the company is developing technologies for delivering biologically active therapeutics.

Companion Technologies (Columbia, South Carolina) has released its MedicWare 4.0 electronic medical records (EMR) software. The new version features an enhanced patient summary sheet that displays information all on one screen, a medical problem list, laboratory results, photo identification, allergy encounters, preventive procedures, and messages. MedicWare also includes functions for prescription writing, HCFA-compliant progress notes, preventive procedure reminders, and review of E&M levels of service.

Computer Motion (Goleta, California) and New York University Medical Center (New York) reported completion of the first minimally invasive robotic heart valve surgery in the U.S. Stephen Colvin, MD, chief of cardiothoracic surgery, and Eugene Grossi, MD, director of cardiac surgical research, used Computer Motion's ZEUS robotic surgical system to perform a minimally invasive mitral valve repair on a 50-year-old man as part of an investigational device exemption Phase I clinical study. With the Zeus system, Colvin and Grossi performed the minimally invasive procedure through a mini-thoracotomy (a 6-cm incision) in the patient's chest. The evening after surgery, the doctors said the patient reported little pain and was mobile and comfortable.

In the mid-1980s, Contrel (Knokke-Heist, Belgium) broke with conventional intrauterine contraceptive devices (IUDs) by developing a simple anchoring system for suspension of the copper "beads" within the uterine cavity. The new GyneFix Mark 11 mini IUD, which is only 2 centimeters long, is put in place using a more simple inserter apparatus with only three procedural steps instead of seven with the previous system.

Integrated Technologies (ITL; Ashford, United Kingdom) has developed a point-of-care instrument for the measurement of total glycated hemoglobin (GHb) which is said to be a more robust and reproducible diabetes control measure than the usual hemoglobin A1c (HbA1c) used in most diabetic clinics. Because of the presence of other hemoglobin variants in the blood of particular population groups – children and patients with sickle-cell anemia – there is a risk that HbA1c results can produce very inaccurate measures of long-term blood glucose control. Measurement of GHb provides a much more realistic measure, according to ITL. Until now, GHb testing required HPLC testing in specialized laboratories, with a 10- to 15-day delay. The company's ABAKA (Automated Blood Absorbance Kinetics Analyzer) system uses affinity chromatography to measure total GHb on a single drop of blood. After each test, the analyzer membrane is back-flushed and primed with a second reagent for the next test, with a cycle time of nine minutes. Regeneration permits reuse for up to 50 tests, although the company says the optimum is around 25. ITL is seeking a marketing partner for this POC instrument, and a production instrument could be ready in less than 12 months.

International Remote Imaging Systems (IRIS; Chatsworth, California) has received FDA clearance to market its 939UDx Urine Pathology System. The company calls the 939UDx "the first full-walkaway system capable of performing complete urinalysis profiles with automatic reporting of microscopic sediment results for most specimens." It was developed in collaboration with scientists at the California Institute of Technology. The 939UDx integrates the Roche Hitachi Chemstrip Super UA Urine Analyzer for urine test strip chemistries, the IRIS imaging flow cytometer for capture of particle images, and the high-resolution ViewStation for recall and display of images and other results in a patented format.

Curon Medical (formerly Conway Stuart Medical; Sunnyvale, California) reported receiving FDA clearance to market its Stretta System for the treatment of gastroesophageal reflux disease, often referred to as chronic heartburn. The procedure is a minimally invasive outpatient procedure using radiofrequency (RF) energy to treat reflux. The RF energy is applied via flexible catheter to the lower esophageal sphincter, improving the barrier function of the valve to stop reflux. The Stretta procedure was evaluated in a clinical study conducted at 16 centers in the U.S. with 130 patients.

Flamel Technologies SA (Lyon, France), a developer of polymer technologies for life science applications, reported that the first clinical study of LABI has been completed on schedule, proving the principle of LABI, formerly known as Basulin, as a long acting human insulin delivery system. The study uses the company's Medusa technology,which will be extended to other therapeutic proteins where dosing regimes may cause poor patient compliance. In this system, specific therapeutic proteins and peptides are encapsulated in nanoparticles. The nanoparticles allow controlled release of the therapeutic agent for slower degradation of the nanoparticle with few or no side affects for the patient.

Lunar (Madison, Wisconsin) received FDA clearance for its Lateral Vertebral Assessment (LVA), an optional application package, for the Prodigy bone densitometer. LVA adds to the list of features on Prodigy, including automated DualFemur and Total Body. The fan-beam design of Prodigy uses a cadmium zinc telluride detector that allows rapid scanning at 10X lower dose for these applications. LVA provides a dual-energy image of the lateral spine for visually assessing vertebral deformations. An existing vertebral fracture has been shown to double the risk of subsequent fractures. Lunar says LVA is superior to competing single-energy imaging, not only because it provides BMD, but also because the dual-energy image resolves the artifacts common in single-energy images of the thoracic spine.

Mentor (Santa Barbara, California) said it received FDA notification that the company's premarket approval application for its saline-filled breast implants has been approved. An FDA advisory panel recommended in March that the implants be approved, as panel members concluded that the data provided reasonable assurance that the products were safe and effective for continued use.

Merit Medical Systems (South Jordan, Utah) has received FDA 510(k) clearance to market its new line of vessel sizing catheters for measuring the inner dimensions of vessels to determine the appropriate therapeutic procedure or interventional device. Fred Lampropoulos, company chairman and CEO, said the introduction coincides with increased demand with the recent approval by the FDA of new endovascular devices such as stent grafts. "Vessel sizing catheters are used to determine the size of a stent to be placed or vena cava filter to be used and, most recently, to properly measure and size stent grafts for AAA (abdominal aortic aneurism) procedures." The new catheters are being sold worldwide through Merit's direct sales force and distribution network.

Minntech (Minneapolis, Minnesota) has submitted a 510(k) filing to the FDA for its endoscope reprocessing products, an automated endoscope reprocessor and companion sterilant, designed to clean and sterilize flexible endoscopes used to examine internal organs and body cavities. Containing sensitive fiber optic mechanisms, flexible endoscopes require careful cleaning and high-level disinfection to prevent the transfer of infections. Minntech provides products and services for dialysis, medical device reprocessing, filtration, and separation.

An FDA advisory panel has backed Organogenesis' (Canton, Massachusetts) plan to market its skin replacement product, Apligraf, as a treatment for diabetic foot ulcers. The General and Plastic Surgery Devices Advisory Committee to the FDA unanimously endorsed the product. The FDA usually follows the advice of its advisory panels, but is under no obligation to do so. Philip Laughlin, president and CEO, said that some labeling issues still need to be addressed. "There are no trials required. We will be interacting with the FDA to hammer out the labeling necessary to get approval." Apligraf was approved in February 1998 for treating venous leg ulcers caused by circulatory problems. An indication in diabetic foot ulcers opens the market for Apligraf to another 600,000 to 800,000 Americans. However, diabetic foot ulcers often are considered more serious because one in five leads to amputation. Diabetics are hospitalized more frequently for foot complications than anything else. Apligraf is an all-natural product engineered from discarded foreskins of human infants. It is living human skin equivalent containing both the epidermis and dermis layers of skin. Rather than using a scaffold for the cells to grow around, Apligraf is made by culturing the cells in a 3-dimensional culture system that yields the two layers of skin. Unlike human skin, Apligraf does not contain blood vessels, hair follicles or sweat glands. Novartis Pharma AG (Basel, Switzerland) has licensed worldwide marketing rights for Apligraf in all indications.

Orthofix (Richardson, Texas) and its partner, HydroCision (Andover, Massachusetts), have received FDA clearance to market a fluidjet-based wound debridement system. Orthofix recently entered into an agreement with HydroCision to serve as exclusive worldwide marketer of that company's TraumaJet, a new wound debridement system. Orthofix predicts product marketing by 3Q00.

QLT PhotoTherapeutics (Vancouver, British Columbia, Canada) and Ciba Vision (Atlanta, Georgia) said the Committee for Proprietary Medicinal Products in Europe recommended granting marketing authorization for Visudyne (verteporfin) therapy to treat wet age-related macular degeneration. The European Commission is expected to make a final decision within the next several months. The therapy was approved in the U.S. in mid-April.

Radiance Medical Systems (Irvine, California) reported receiving a U.S. patent, "Radiation Delivery Catheter," covering a number of product designs surrounding its radiation delivery technology. Radiance Medical develops site-specific catheters for the delivery of radiation to prevent restenosis following the interventional treatment of atherosclerosis. The company has more than 16 patents covering a broad range of methods and design applications of both the Focus and Radiation Delivery technologies and a similar number of patent applications for the RDX Coronary Radiation Delivery System under clinical investigation in Europe and the U.S.

Respironics (Murrysville, Pennsylvania) reported the U.S. and international market launches of its Stardust Sleep Diagnostic Device. A seven-channel, three sensor, portable sleep diagnostic tool, the Stardust is a small, lightweight recorder that can be used in either the home or a sleep lab, according to Respironics. Worn on the chest, physiological data is sent via sensors plugged directly into the recorder, allowing patients more freedom of movement while they sleep, compared to larger sleep diagnostic units. The data is downloaded and analyzed by StarDust's host software, which is based on the Alice 4 technology used in Respironics' more sophisticated sleep lab systems. "The simplicity of Stardust allows the health care provider the flexibility to send the unit home with a patient for initial sleep studies or follow-up studies to ensure compliance," according to John Miclot, Respironics' home care division president.

Siemens Medical Systems (Iselin, New Jersey) has received conditional FDA approval to continue clinical testing of the Siemens Sonocur, a sound wave therapy device marketed in Europe and Canada for the treatment of chronic orthopedic pain. In the U.S., clinical evaluation of the Sonocur as a pain therapy system has been underway since 1999 and has focused on the treatment of patients with lateral epicondylitis, commonly known as chronic tennis elbow. With the conditional approval, Siemens will continue clinical testing of the system at four U.S. study sites. Additionally, the Ultrasound Group of Siemens Medical Systems said that its 5.0 software upgrade to the Sonoline Elegra ultrasound system includes new DICOM features for the integration of text and image data into existing hospital-wide information and picture archiving and communication systems.

Somanetics (Troy, Michigan) reported on a clinical study of regional low-flow perfusion, a new bypass management technique, the procedure greatly reduced circulatory arrest time required for aortic arch reconstruction. By maintaining cerebral hemoglobin volume and cerebral oxygen saturation at reasonable levels during these surgeries, as monitored by Somanetics' INVOS Cerebral Oximeter, brain injuries in these patients may be reduced. Frank Pigula, MD, department of pediatric cardiothoracic surgery, Children's Hospital of Pittsburgh (Pittsburgh, Pennsylvania), presented his study results during the recent American Association for Thoracic Surgery Congenital Heart Disease Symposium. The INVOS Cerebral Oximeter non-invasively and continuously monitors changes in the regional oxygen saturation of the blood in the adult brain. Somanetics has applied for FDA clearance for its pediatric cerebral oximeter, and related clinical studies under various pediatric investigational exemptions are under way.

Sonic Innovations' (Salt Lake City, Utah) Conforma, an instant, high-tech digital hearing aid, is available for national distribution. Conforma has been tested and test-marketed across the U.S., with a particular emphasis on targeting aging baby boomers. Conforma consists of two parts. The first is a tiny core, about the diameter of a pencil eraser, that houses the product's electronics and a small, powerful computer chip. The second is a disposable, "squishy" soft shell that fits snugly over the aid's core. Since the soft shell comes in four standard sizes, there is no need to wait 1 to 2 weeks for ear impressions to be made into the hard, acrylic shells that are characteristic of traditional hearing aids. Conforma's shell molds itself to the shape of the wearer's ear canal, making a complete, comfortable and flexible seal, thereby providing a custom fit with every use. Its soft shell is replaced each week; wearers simply remove the core and insert it into a fresh shell.

STS Biopolymers (Henrietta, New York) said it has developed the Graft-Coat surface modification technology. This reversed-phase graft polymerization technology allows a variety of polymer layers to be permanently bonded to even the most difficult-to-coat polymer surfaces, according to the company. Chairman Richard Whitbourne said, "a major benefit of this technology is the ability to coat medical device surfaces, including catheter lumens and odd-shaped geometries, without the use of plasma, gamma or UV radiation." Graft-Coat can permanently adhere to most polymer surfaces, particularly inert substrates such as silicone, latex, polyethylene, and fluoropolymers like Teflon.

Thoratec Laboratories (Pleasanton, California) has received FDA approval for its investigational device exemption supplement containing validation data for a new component for its TLC-II Portable VAD (Ventricular Assist Device) Driver. Shipments were made immediately to investigational sites that have both investigational review board approvals and patients potentially eligible for enrollment. In October 1999, Thoratec put a voluntary hold on further patient enrollment in the U.S. clinical trial, initiated in April 1999, and on shipments to new European centers where it has been approved for sale for two years -- pending completion of a component upgrade. The TLC-II is a small, lightweight device used to power Thoratec's VAD, which pumps blood the blood of heart failure patients awaiting transplants or recovery from open-heart surgery. It is designed to enable patients to leave the hospital and be discharged to managed care facilities or their homes. The company says it is the only portable cardiac assist device that can treat patients by providing left, right or biventricular support.

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