Offering proof that it pays to try again, Sunrise Technologies International (Fremont, California) won a recommendation of approval from the FDA's Ophthalmic Devices Panel for its Hyperion Laser Thermal Keratoplasty (LTK) System in the U.S. The approval is for the temporary reduction of low-to- moderate hyperopia (or farsightedness) in the range of +0.75 to +2.50 diopters, with conditions. The term "temporary" is important, since the company last July was rebuffed by the panel when it sought approval for providing "correction" of mild-to-moderate hyperopia. In its follow-up application, Sunrise sought an application for reduction of this range of hyperopia, with the understanding that the effect may fade over time. Thus, one of the conditions required by the panel is that the company use the word "temporary" in describing effect of treatment. The panel also required labeling language describing potential patient symptoms and the effect of retreatment.

Unlike other corneal lasers that may involve cutting the cornea, the Hyperion system sends rings of laser light around the field of vision, causing the cornea to change shape and "steepen" by warming and shrinking it. No instruments touch the eye, and no corneal tissue is cut or removed during the procedure, thus reducing potential morbidities. "This is a victory for ophthalmology and the farsighted patients in the United States," said C. Russell Trenary III, president and CEO of Sunrise Technologies. "We eagerly look forward to working closely with the FDA in the coming weeks to obtain final approval for the Sunrise Hyperion LTK System, which is the first technology designed specifically for the treatment of farsightedness."

As part of the company's presentation before the advisory panel, several people attended to report their experiences with the treatment. Among them was Charles Kelman, MD, who underwent the procedure in its clinical trials. Kelman described the difference between hyperopia and myopia as severe. "When you are hyperopic such as I am, you have no clear distance or near vision. I had been wearing contacts, but was at a point that I had to do something because my eyes were becoming too dry to wear them comfortably. I looked very carefully at the procedures available for treatment of hyperopia, and decided that LTK was the best option."

Jeannie Cecka, Sunrise's vice president of clinical and regulatory affairs, reviewed the data on procedures for 612 eyes, saying that "patients experienced a significant improvement in their visual acuity from preoperative levels with virtually no side effects."

Sunrise estimates a large potential market for the Sunrise Hyperion LTK System, since hyperopia is the most common refractive error in the U.S. population, according to a study conducted by investigators from Johns Hopkins University (Baltimore, Maryland) and supported by grants from the National Institutes of Health (Bethesda, Maryland). The study revealed that by the end of this year, nearly 118 million Americans will be age 40 and over, and about 60 million of them will be hyperopic. Of these 60 million, about 62%, or 37 million, are expected to have low to moderate hyperopia from +0.75 to +2.50 diopters (the initial application for approval of the Sunrise Hyperion System); 30%, or nearly 28 million, will have hyperopia from +2.75 to +4.0 diopters; and 8%, or nearly 5 million, will have hyperopia of more than 4.0 diopters (the measure of the focusing power of the eye). Two rings of laser energy are applied to the mid-periphery of the cornea at the 6 and 7 millimeter zones, gently heating the collagen. This shrinks the collagen, causing the cornea to steepen.

Elsewhere in the product pipeline:

Abiomed (Danvers, Massachusetts) has received FDA approval of its PMA supplement covering an additional arterial cannula, or cardiovascular connector, to be used with the company's BVS-5000 biventricular assist device. The BVS can temporarily take over the full pumping function of the heart to support patients with potentially reversible heart failure, allowing their failing hearts the opportunity to rest, heal and fully recover. The cannula is surgically attached to a heart's ascending aorta or pulmonary artery during the implantation of the BVS. Composed partially of a Hemashield graft, the cannula is smaller than prior BVS cannulae to allow maintenance of proper blood flow. The BVS is now available in more than 80% of all major medical centers that perform over 500 heart surgeries annually.

Acuson's (Mountain View, California) AcuNav diagnostic ultrasound catheter has received 510(k) clearance. The product, the result of a collaboration between the company and cardiologists at the Mayo Clinic (Rochester, Minnesota), provides better visualization of the heart during diagnostic and therapeutic procedures. "This device enables us to clearly see areas of anatomy that govern heart function we have not been able to visualize previously," said James Seward, a Mayo Clinic cardiologist, director of its echocardiography laboratory and one of the inventors of the AcuNav. "This catheter with the eyes of ultrasound allows for more precise imaging within the heart and blood vessels."

Biopure (Cambridge Massachusetts) said Health Canada's Bureau of Biologics and Radiopharmaceuticals has reviewed its investigational new drug submission for the oxygen therapeutic Hemopure (hemoglobin glutamer – 250 [bovine]) and has allowed the company to expand its Phase III clinical trial of the product into Canada. The trial is evaluating Hemopure as a room-temperature, stable, universally compatible alternative to red blood cell transfusion in orthopedic surgery. "Expansion of our clinical trials into other countries serves to broaden the medical community's understanding of the underlying physiology of Biopure's oxygen therapeutics and their potential application both as a red blood cell substitute and in other medical conditions where tissue oxygenation is beneficial," said Carl Rausch, chairman and CEO. As of October 1999, Biopure's Phase III clinical trial had enrolled more than half of the required 640 patients and had expanded to more than 30 clinical trial sites in the U.S., Europe and South Africa. The company said it plans to complete this trial and file a marketing application in the U.S. during 2000, followed by applications in Canada and the European Union.

Biovail International (Mississauga, Ontario, Canada) has received approval from the FDA for its generic version of Cardizem CD, which is indicated for the treatment of hypertension and angina. Teva Pharmaceuticals USA (Sellersville, Pennsylvania), Biovail's marketing partner, will launch the product immediately in all dosage strengths.

Cook (Bloomington, Indiana) has introduced the Surgisis soft-tissue graft, a natural acellular biomaterial, for the repair, support and stabilization of a wide variety of anatomical defects and traumatic injuries. Surgisis uses Cook Biotech's SIS technology, a tissue-engineered collagen matrix derived from the porcine small intestinal submucosa (SIS), to model the qualities of its host when implanted in human soft tissues. It is available in a variety of sizes and strengths, in sheet form that may be cut, rolled or folded to accommodate specific anatomical requirements. Cook's Oasis wound dressing, which also uses SIS technology, also is now available for the treatment of partial-thickness skin injuries such as burns, abrasions, pressure and chronic vascular ulcers and autograft donor sites. The product is available in single-thickness, fenestrated sheets 7 centimeters wide by 10 or 20 centimeters long.

CryoLife (Kennesaw, Georgia), a developer of living human tissue implantable devices and a manufacturer and distributor of stentless heart valves and surgical adhesives, has submitted an FDA investigational device exemption supplement to expand a clinical study of its BioGlue surgical adhesive. The supplement requests an expansion to include using BioGlue in vascular and certain cardiac repairs, in addition to the commercially approved usage as an adjunct to the original application for acute thoracic aortic dissections approved this past December. Shipments of BioGlue to U.S. hospitals began in early January.

Demegen (Pittsburgh, Pennsylvania) has been awarded a U.S. patent for promoting healing of surgical wounds with amphipathic peptides by stimulating growth of dermal tissue. The patent, "Method of Enhancing Wound Healing by Stimulating Fibroblast and Keratinocyte Growth in Vivo, Utilizing Amphipathic Peptides," is Demegen's seventh U.S. patent and the second specifically addressing wound healing. Demegen also is currently completing preclinical evaluation of a product to prevent and treat infected wounds in preparation for human clinical trials.

EDAP TMS (Vaulx-en-Velin, France) has submitted its 30-minute TUMT Prostatron for FDA approval. The new procedure reduces treatment time from one hour to 30 minutes. "Clinical trials in Europe and North America have shown the 30-minute Prostatron to result in significant improvements in patient symptom score, flow rates and quality of life for patients suffering from [benign prostatic hyperplasia]," the company said in a statement.

Guidant (Indianapolis, Indiana) said it has received FDA clearance to market its ACS Multilink RX Tristar and ACS Multilink OTW Tristar coronary stent systems, already sold in Europe and accounting for 75% of the firm's European stent sales. The Tristar system is indicated for use in first-time blockages and restenotic, or recurring, lesions in native coronary arteries. It is pre-mounted and balloon-expandable and available on both rapid-exchange and over-the-wire platforms.

Hemosol (Toronto, Canada) reported completing a U.S. Phase II cardiac bypass study of Hemolink, its first hemoglobin replacement product, or blood substitute, and that the results were positive. Closed this past November, the trial was conducted in nine U.S. centers, following 60 patients undergoing coronary artery bypass grafting (CABG) surgery. Results demonstrated Hemolink as safe in this patient population, and there were no clinically limiting side effects, according to the company's report. Also, study patients who received 750 ml of Hemolink required significantly less donor blood than patients in the control arm. The company said the results are consistent with previously reported Phase II results from a similar study conducted at seven sites in Canada and the UK, completed early in 1999. The company also said that the pivotal Phase III CABG trial in Canada and the UK is continuing to enroll patients.

Immunomedics (Morris Plains, New Jersey) has received U.S. Patent No. 6,010,680 for a method of radiolabeling proteins by use of a new radio metal-binding compound composed of mercaptobutyryl glycinate ligands. The compound enables chemical binding of a broad array of radiometal imaging and therapeutic isotopes to various proteins, including antibody fragments, albumin, drugs, cytokines, enzymes, hormones, immune modulators, and receptors, according to Dr. David Goldenberg, company chairman and CEO. "This new patent adds important technology to two other U.S. patents [nos. 5,958,408 and 5,965,131] issued in September and October of 1999, involving improvements in pretargeting methods for delivering diagnostic or therapeutic agents to diseased tissues, and using different classes of targeting and therapeutic agents," he said.

INO Therapeutics (Clinton, New Jersey) has received FDA approval for INOmax (nitric oxide), an inhaled pulmonary vasodilator for the treatment of full-term and near-term neonates with hypoxic respiratory failure. It is used in conjunction with ventilatory support and other appropriate agents. INOmax dilates the blood vessels of the lungs so they can carry more oxygen, and in doing so reduces the need for the invasive surgical procedure extracorporeal membrane oxygenation in infants with clinical or echocardiographic evidence of pulmonary hypertension, according to the company. INOmax will be launched in the first quarter of 2000, and will be bundled in a package consisting of the drug, a delivery device, equipment maintenance and service and 24-hour support for health care professionals.

IntraLase (Irvine, California) said in mid-January that the FDA had granted 510(k) clearance for its Femtosecond Laser Keratome System. The system will be marketed as an alternative to microkeratomes that use blades to create a corneal flap prior to vision correction procedures. Randy Alexander, company president and CEO, said the Femtosecond laser system will provide refractive surgeons "with an entirely new level of safety and control for performing lamellar resections of the cornea." More than 1 million laser vision correction procedures using mechanical microkeratomes were performed in the U.S. last year. Tibor Juhasz, vice president of R&D at IntraLase, said the laser keratome "is only the first and simplest application of this ... technology, with many new applications on the horizon."

IntraTherapeutics (St. Paul, Minnesota) reported receiving approval from the Japanese Ministry of Health and Welfare to begin sales of its IntraStent Biliary Endoprosthesis, used to eliminate blockages in patients with obstructed bile ducts. The device is made of stainless steel and is balloon expandable. The IntraStent is cleared in the U.S. for biliary use and has the European CE Mark for renal, iliac and subclavian artery stenting. It is the first of IntraTherapeutics' products to be approved in Japan and will be sold through Getz Bros., a distributor of specialty medical devices. IntraTherapeutics makes devices for the treatment of peripheral vascular disease and non-vascular obstructions.

Luxtec's (Worcester, Massachusetts) Fiber Imaging Technologies subsidiary and its German partner, Schoelly Fiberoptic, have received 510(k) approval to market a line of arthroscopes in the U.S. The FDA approval enables the unit to offer the arthroscopic telescopes to original equipment manufacturers for incorporation into vision subsystems sold to surgeons and physicians. The rigid-rod arthroscopes are incorporated with lighting, video and monitoring products to improve visibility of operative sites and to enable documentation of arthroscopic procedures on the knee, shoulder, jaw, wrist, ankle and elbow, Luxtec said in a statement.

Medtronic (Minneapolis, Minnesota) has introduced the Octopus 2+ tissue stabilization system, which builds upon the success of its predecessor, the Octopus 2, by incorporating improvements designed to further reduce tissue motion and improve multivessel access during beating-heart surgery. Medtronic's Octopus tissue stabilization systems employ suction to gently lift and hold the surface of a beating heart almost motionless while grafted vessels are sutured into place. The 2+ system features a new, four-cup pod stabilizer design and a stronger articulating arm that permits the stabilizer pods to be positioned along various cardiac arteries. It also allows a more controlled spread of the stabilizer pods to optimize exposure of the grafting site.

The Department of Energy's Oak Ridge National Laboratory (Oak Ridge, Tennessee) has received two broad U.S. patents related to microfluidic chip technology. This brings to four the number of patents held by the laboratory, with Caliper Technologies (Mountain View, California) holding a license in a specific field to all of these patents. All entitled "Apparatus and Method for Performing Microfluidic Manipulations for Chemical Analysis and Synthesis," the four patents cover a system – termed "virtual valve" technology – for precise control of the flow of materials at intersections of channels in microfluidic chips without mechanical valves. This process is used in a variety of analytical applications, including DNA and RNA analysis, protein analysis and high-throughput drug discovery.

Organogenesis (Canton, Massachusetts) has submitted to the FDA a supplemental premarket approval application for Apligraf (Graftskin) for use in diabetic foot ulcers. If approved, Apligraf, currently indicated for use in the treatment of venous leg ulcers, will be the first bilayered skin product approved for the treatment of diabetic foot ulcers. Of the 16 million people in the U.S. with diabetes, one in every seven is expected to suffer from at least one diabetic foot ulcer. Complications lead to amputation, 50,000 to 70,000 procedures of which are performed on diabetics in the U.S. each year. Apligraf is marketed in the U.S. by Novartis Pharmaceuticals (East Hanover, New Jersey).

The FDA has granted to Polymer Technology Systems (Indianapolis, Indiana) conditional approval to begin investigational testing of an implantable device for testing of body fluid collected subcutaneously and combines a device called the Capillary Filtrate Collector (CFC) and an electromechanical device called the Filtrate BioScanner that measures glucose levels in the ultrafiltrate collected via the CFC. Initial clinical studies will be performed on diabetic surgical patients by following the patient with correlating fingerstick glucose in the operating room, and then for two hours in post-op.

Sabratek's (Skokie, Illinois) Rocap division has received 510(k) approval for its heparin IV flush syringe products. Approval came after Sabratek in November 1998 voluntarily ceased distribution of the flush products, consisting of both FDA-approved syringes and heparin/saline, until the FDA, which had declared the company's prefilled syringes a device, approved the latter as such. Sabratek filed for bankruptcy under Title 11 in early December and earlier announced it had signed an asset purchase agreement with Baxter Healthcare (Deerfield, Illinois) under which Baxter has offered to purchase certain assets, including, among other things, the Rocap prefilled syringe business and selected liabilities.

SonoSite's (Bothell, Washington) SonoHeart hand-carried echocardiography system has received 510(k) premarket clearance from the FDA. The system weighs 5.4 pounds and delivers all-digital echocardiography with 2D and PowerMap directional color power Doppler images on demand.

Spacelabs Medical (Redmond, Washington) has introduced the Ultraview Web Source CM, a telemedicine product that allows caregivers to remotely access, via the Internet, electronic patient records and other software applications used in patient care, such as previous medical encounters, treatment information, vital signs, streaming waveforms and ECG records. It is part of the Ultraview Care Network family of products that provide monitoring for all critical-care environments. The first installation of WebSource CM is scheduled for the first quarter at the Spartanburg Regional Health Care System (Spartanburg, South Carolina). It will include an electronic interface to the McKesson HBOC (San Francisco, California) Pathways Image Manager.

SpectRx (Norcross, Georgia) reported receiving a $700,000 milestone payment from Welch Allyn (Skaneateles Falls, New York) as a result of clinical trials demonstrating the feasibility of its noninvasive biophotonic cervical cancer detection prototype device. The device uses SpectRx's proprietary technology to locate cancers and precancers by shining light on the cervix. Light reflected back from the cervix is analyzed and differentiates normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. The prototype devices demonstrated sensitivity in three studies ranging from 89% to 100% (0% to 11% false-negative rate) and specificity ranging from 80% to 89% (11% to 20% false-positive rate). The company said that, by contrast, for patients where Pap test data could be obtained, the Pap test classified 30% of cancerous and precancerous lesions as normal or infection for a sensitivity of 70% (30% false-negative rate), with a corresponding specificity of 72% (28% false-positive rate).

St. Jude Medical (St. Paul, Minnesota) reported the first implants of the Photon DR implantable cardioverter defibrillator (ICD) with dual-chamber pacing capabilities. Malte Meesman, MD, of the Medizinische Universitatsklinik (Wurzberg, Germany), implanted the ICD device in December in a 57-year-old female patient who had survived an episode of sudden cardiac death. Jorg Neuzner, MD, of the Kerckhoff-Klinik (Bad Nauheim, Germany), implanted the second device in a 58-year-old male patient with syncope and ventricular tachycardia. St. Jude also said it is launching a new cardiac pacing lead in the European market that it calls the thinnest of its type in the world. The Tendril SDX lead employs an extendable-retractable helix for active fixation in either the atrium or the ventricle. It also incorporates a steroid-eluting tip that reduces inflammation and pacing thresholds. Its small diameter facilitates implantation to reduce operative time and surgical trauma.

Vital Images (Minneapolis, Minnesota) has released for shipment the Vitrea 2, a Microsoft Windows NT-compatible version of its Vitrea visualization and analysis software for surgical planning and the noninvasive diagnostic evaluation of computed tomography and magnetic resonance imaging data. Vitrea 2 is the company's first 3-D volume visualization software product available for the Windows NT platform, and features increased speed and functionality.

Vital Signs (Totowa, New Jersey) introduced at the American Association of Respiratory Care conference two new products: the Pocket Blue, a first-responder resuscitator, and the Aspirator Plus arterial blood gas syringe. The Aspirator Plus is designed to keep air contamination out of the arterial blood sample through a filter that separates air behind the blood. The Pocket Blue is intended to provide more protection to the responder and victim during the resuscitation phase of CPR. Vital Signs and its subsidiaries design, manufacture and market single-use medical products for anesthesia and critical care. Its products have received the CE Mark and ISO 9001 certification.