Acclarent (Menlo Park, California) unveiled a new treatment option for sinusitis, the Balloon Sinuplasty procedure, last month at the annual American Rhinologic Society (ARS; Bronx, New York) meeting in Los Angeles. Instead of conventional sinus surgery, which involves bone and tissue removal, the Balloon Sinuplasty procedure is designed to thread what the company called a “small, flexible balloon” through the sinus passageways, thereby dilating the openings of the sinuses and allowing for immediate drainage.

“The whole reason why we’ve developed the technology is we believe that there is an opportunity for a more minimally invasive approach,” William Facteau, president and CEO of Acclarent, told The BBI Newsletter. “There are 37 million Americans that suffer from chronic sinunitis, so the prevalence is very high.”

Typically, non-surgical approaches to treat sinusitis involve antibiotics or topical steroids, delivered as nasal sprays, “which just like any other medical therapy [are] burdensome, expensive [and] they introduce their own side effects.”

Facteau also said that about 25% of the patients who go on steroids or antibiotics “can actually be refractory to the meds, so they don’t work.”

The surgical option is what is known as functional endoscopic sinus surgery, or FESS. It is estimated that about 350,000 of these procedures are performed in the U.S. alone each year. However, he noted that there is “a large portion of the patients, almost two times” that number who are referred to have the FESS procedure but elect not to due to fears of pain associated with the procedure or hesitation about going under general anesthesia.

“We believe there’s an opportunity for a middle ground, if you will,” said Facteau. “Just like in other areas, [such as] cardiovascular,” the Relieva Sinus Balloon Catheter expands the area within the sinus. The guidewire is inserted and guided with the help of X-ray.

Acclarent’s procedure involves threading a guidewire into the sinus passage and passing in a balloon catheter over the wire to the targeted sinus, he said. “What makes our procedure so unique is that we actually have a proprietary process or coating on our balloon that allows us to make a very small fracture in the bone, thereby creating an opening that allows for normal drainage to happen in the sinuses.”

Facteau said the bone is “a kind of very thin, corn flake-like bone” that is different in every patient. He explained that the advantage of Balloon Sinuplasty is that it allows for the preservation of bone, which does not have to be removed, and the submucosa, or a carpet-like lining in the sinus cavities.

“The goals of surgery right now are to create an opening and try to preserve as much of that mucosa and bone as possible,” he said, noting that after the “microfracture” the healing process begins.

Elsewhere in the product pipeline:

• Alcon (Fort Worth, Texas) said it has received FDA approval for the AcrySof Toric intraocular lens (IOL) for use in cataract patients with pre-existing corneal astigmatism. The AcrySof Toric lens is based on the AcrySof single-piece IOL design and acrylic material platform. It incorporates an optical design that the company said corrects for pre-existing astigmatism in cataract patients resulting in significantly improved distance visual outcomes. Alcon said it is targeting commercial launch of the AcrySof Toric lens in conjunction with the annual meeting of the American Society of Cataract and Refractive Surgeons in March 2006.

• ArthroCare (Austin, Texas) reported the launch of its LabraFix System, a knotless arthroscopic repair technology. The LabraFix System is designed to provide orthopedic surgeons with an enhanced arthroscopic approach to repairing labrum tears (Bankart and SLAP lesions) without having to tie complex and time-consuming surgical knots. The company said the enabling technology has the potential to lower procedure costs by minimizing surgery time. The system consists of two components – the SpeedStitch Suturing Device and the MiniMagnum Knotless Implant. Used together, they enable the surgeon to arthroscopically repair the torn labrum quickly and securely, ArthroCare said, providing “a strong and reproduc-ible tissue-to-bone fixation due to a tissue tensioning mechanism, a superior bone lock or hold, and a secure knotless suture lock.”

• ATS Medical (Minneapolis) has introduced the ATS Medical Thoracic Port System, which incorporates new technology designed to complement robotic surgery and bring what the company termed “significant improvement” to minimally invasive cardiac surgery procedures. Consisting of stainless steel ports in six sizes, the ATS Medical Thoracic Port System “facilitates excellent visibility in the chest without interrupting the surgical field,” ATS said. It said that “painful rib spreading” is eliminated and travel of fat and tissue into the chest cavity is minimized, lowering the risk of embolization. The components of the system are sterilizable and reusable, ATS said.

• Beckman Coulter (Fullerton, California) said it has begun shipping the Vidiera NsP Nucleic Sample Preparation platform, which it refers to as a versatile new solution for nucleic acid isolation, quantification, normalization and reaction set-up for downstream assay analysis. Vidiera NsP is based on the company’s Biomek automation and diagnostic primary tube-handling technologies and is designed, Beckman Coulter said, to meet the growing need for molecular testing in hospital and reference laboratories. The company said Vidiera NsP is “ideal for molecular diagnostic applications in virology and pathology” and can be integrated with its recently introduced Vidiera NsD Nucleic Sample Detection System.

• A pediatric heart pump assist device made by Berlin Heart (Berlin, Germany) has been implanted in a 3-month-old boy at Texas Children’s Heart Center (Houston), likely the smallest person in the U.S. to receive the device. The Berlin ventricular assist device was implanted in a five-hour procedure on Sept. 27, as a “bridge” to the time he can receive a heart transplant. Charles Fraser Jr., MD, chief of cardiovascular surgery at Texas Children’s, performed the surgery.

• Bioheart (Sunrise, Florida) said the U.S. Patent and Trademark Office has issued a notice of allow-ance regarding two of its patent applications – 10/152,110, titled “Deflectable Microimplant Delivery System” and 10/181,741, titled “Apparatus for Inserting Particles Into Tissue.” The patent applications, acquired by Guidant (ndianapolis) in June 2003 and licensed back to Bioheart on a co-exclusive basis, cover delivery systems for delivering cells, therapeutic agents, particles and/or other biologics.

• Biophan Technologies (West Henrietta, New York) and New Scale Technologies (Victor, New York), a developer of miniature ceramic motors, said the U.S. Patent and Trademark Office has granted New Scale Technologies a fundamental patent for its Squiggle motor. Made of piezoelectric ceramics and other non-magnetic materials, the small Squiggle motor has applications in numerous industries, and Biophan holds exclusive worldwide distribution rights for all medical applications. Benefits of the motor for medical devices include low heating, low noise, high precision and longer battery life. Biophan and New Scale said they expect the motor’s design to offer precision and reliability for such applications as implantable and wearable drug-delivery pumps. The motor also is safe and image-compatible for use in MRI systems, so the companies said they believe it will enable the creation of novel MRI-compatible biomedical devices. Biophan has a minority equity position in New Scale Technologies.

• Bone Solutions (BSI; Dallas) said it has successfully tested its magnesium-based orthopedic adhesive technology in multiple studies to prove full biocompatibility for injection into animals and humans, with mechanical properties that gave it “unusual strength and performance beyond current orthopedic industry products.” BSI said its bone void filler/cement/adhesive is expected to be deployed for many “significant” orthopedic surgeries, enhancing bone, ligament and tendon repairs once FDA 510(k) approval is received.

• Cardiovascular Systems (CSI; Minneapolis) said it has received conditional investigational device exemption (IDE) approval from the FDA to begin its clinical trial of its Orbital Atherectomy System for treatment of peripheral artery disease at two sites. The trial is eventually expected to enroll a total of 124 patients at up to 10 centers. Full approval is contingent upon agency approval of an IDE supplement that has been submitted following some informed consent changes requested by the FDA, and after 30-day follow-up of the first 10 patients. The Orbital Atherectomy Device uses a diamond-coated, rotating cutting surface to ablate tissue. The company said it is working on obtaining approval of an IDE for using the system to treat occluded coronary arteries and also is conducting a post-approval clinical trial in Europe to treat peripheral vascular disease, with plans for a European coronary trial in early 2006. The system is CE-marked for peripheral use.

• The new Active Cooling Vest from CoolSystems (doing business as Game Ready; Berkeley, California) is helping surgeons stay cool by delivering active cold therapy and adjustable compression to the upper torso and back to pull heat away from the body. Game Ready’s core line of cold therapy and intermittent compression products have been used to help orthopedic surgery patients recover post-operatively and help sidelined athletes get back on top of their game. The company’s ergonomic wraps and cooling systems are founded on National Aeronautics and Space Administration spacesuit technology and based on the common procedure for treating acute sports injuries of rest, ice, compression and elevation, or R.I.C.E. The Active Cooling Vest is a new extension of this core product line.

• Eastman Kodak (Rochester, New York) said it has obtained FDA approval for enhancements to its mammography computer-aided detection (CAD) system. New software for the Kodak Mammography CAD System increases the system’s sensitivity to microcalcification clusters while reducing the number of false-positive markers.

• Edwards Lifesciences (Irvine, California) re-ported the European and U.S. launch of a new mitral valve repair therapy specifically designed to treat the leaky mitral valve of patients suffering from congestive heart failure (CHF). The Edwards GeoForm annuloplasty ring, which features a 3-D shape, has been shown to successfully treat mitral valve regurgitation caused by cardiomyopathy, a common form of CHF that affects tens of thousands of people annually, and improve the function of the left ventricle, according to a presentation at the annual meeting of the European Association for Cardio-thoracic Sur-gery (Windsor, UK). Steven Bolling, MD, professor of surgery and director of the University of Michigan Health System’s (Ann Arbor) Mitral Valve Clinic, presented results from a prospective study of 16 congestive heart failure patients, all of whom were suffering from mitral valve regurgitation due to distortion of their heart’s left ventricle. Six months after the patients’ mitral valves were surgically repaired with the GeoForm annuloplasty ring, their mitral valve regurgitation was eliminated and the left ventricle was reformed. Edwards developed the GeoForm ring in conjunction with Ottavio Alfieri, MD, of St. Raffaele Hospital (Milan, Italy) and Bolling.

• Eli Lilly & Co. (Indianapolis) and Alkermes (Cambridge, Massachusetts) presented at the 41st annual meeting of the European Association for the Study of Diabetes in Athens, Greece, results from a Phase II clinical study of inhaled insulin in people with Type 1 diabetes. The study showed that patients using the Lilly/Alkermes inhaled insulin system achieved blood sugar levels similar to patients treated with injected insulin. In addition, 80% of patients in the study expressed a preference for the Lilly/Alkermes inhaled insulin system at mealtime over injected insulin. Patients achieved an average A1c level of 7.9 using the Lilly/Alkermes inhaled insulin system, compared to 8.0 in the injected insulin group.

• GE Healthcare (Waukesha, Wisconsin) has unveiled what it termed “major pediatric application enhancements” for its Lunar Prodigy bone density system. The enhancements provide tools to evaluate the pediatric skeleton relative to a child’s body size and skeletal age, in addition to the conventional chronological age comparison. The new application was presented during the American Society for Bone and Mineral Research annual meeting in Nashville, Tennessee. Dual-energy X-ray absorptiometry (DXA) is the method of choice in evaluating bone mineral density (BMD) in children, but accurate assessment of the pediatric skeleton is more challenging due to the wide range of body sizes and rates of skeletal growth seen in children. Previously, manufacturers of bone densitometry systems assumed a constant standard deviation in reference data for all children regardless of their age, but results have shown that BMD standard deviations vary considerably with age, especially in the years of most rapid growth. GE Healthcare said use of age-dependent standard deviations on Lunar equipment provides a more accurate comparison to reference.

• Gen-Probe (San Diego) reported last month that the FDA has notified it that the agency considers the Procleix Tigris system “not substantially equivalent” to the Procleix enhanced semi-automated system (eSAS) for screening donated human blood with the Procleix Ultrio assay. The FDA made the determination in response to the company’s 510(k) application for the Tigris system. The company said it has discussed the determination with the agency and is scheduling “a series of meetings” to resolve outstanding issues. Gen-Probe previously won 510(k) marketing clearance for the eSAS system used to screen donated human blood using the Ultrio assay. The company said it also continues to expect approval of its biologics license application for the Ultrio assay this year. The Ultrio assay, Tigris system and eSAS system all are approved for commercial blood screening use in many countries outside the U.S.

• Genzyme (Cambridge, Massachusetts) reported the commercial availability of a new laboratory test to help identify patients likely to respond to therapies targeted for the treatment of non-small cell lung cancer (NSCLC). Genzyme’s EGFR Mutation Assay will help to detect the presence of epidermal growth factor receptor (EGFR) mutations in patients with NSCLC. EGFR mutations have been shown to correlate with clinical response to certain drugs, including Tarceva (erlotinib) and Iressa (gefitinib), used in treating this deadly form of cancer. According to Mara Aspinall, president of Genzyme Genetics (Westborough, Massachusetts), the company division responsible for developing these tests, this and other targeted diagnostics for cancer are part of a growing trend to help physicians determine the best course of treatment for a patient as soon after a diagnosis is made as possible. “With this test, the rationale for prescribing specific lung cancer therapies may be individualized, and we can help physicians and patients choose the best treatment possible,” she said. “This is ‘personalized medicine’ in action.”

• Iridex (Mountain View, California), a provider of semiconductor-based laser systems for the ophthalmology and dermatology markets, reported that it has introduced its new OcuLight OR (532 nm) green laser, expanding its OcuLight product line offering and allowing the company to enter the ear, nose and throat market. The solid-state laser system can be used in the operating room environment by otologists for otosclerosis and by ophthalmologists for retinal photocoagulation, which will allow hospitals to use one standard laser platform across specialties and one laser console to satisfy operating room needs. The laser was shown to otologists for the first time at the recent American Academy of Otolaryngologists meeting in Los Angeles.

• Kensey Nash (Exton, Pennsylvania) said the FDA has allowed expanded indications of its BioBlanket Surgical Mesh. The expanded indications specifically allow the product to be used for the repair of hernias and reinforcement of soft tissue in rotator cuff repair surgery, which the company said are two of the important target markets for the technology. The expanded indication also allows the product to be used in a wide variety of other surgical procedures, including repair of defects in the thoracic wall, rectal and pelvic floor reconstruction procedures, among others. BioBlanket is a resorbable collagen sheet technology, intended for use in surgical procedures as a patch for reinforcement and repair of ruptured or damaged soft tissues. Since the product’s initial clearance by the FDA last year, Kensey Nash has been broadening the base technology for applications in rotator cuff repair and other procedures. It said additional development work would continue prior to commercial release of any of the potential products.

• In a move that takes the company one step closer to having a drug-eluting stent (DES) on the U.S. market, Medtronic (Minneapolis) reported last month that it had submitted its first pre-market approval (PMA) module to the FDA for the Endeavor coronary stent system. This action represents the first step by the company in the U.S. approval process for Endeavor stents. Scott Ward, president of Medtronic Vascular (Santa Rosa, California), said the company has worked “diligently” with the FDA to develop a well-designed schedule of modular submissions that meet the agency’s requirements for the Endeavor stent and the new molecular entity, ABT-578. He said the modules would reflect the depth of the entire ENDEAVOR clinical trial program, including key safety data from the current ENDEAVOR IV trial. By the time the final PMA module is submitted, Medtronic will have safety and efficacy data on more than 2,000 patients implanted with the Endeavor stent. The stent, which received the CE mark in late July, is made of a cobalt alloy and has a modular architecture designed to enhance deliverability over standard bare-metal stents. In addition to the drug compound ABT-578, a drug compound licensed from Abbott Laboratories (Abbott Park, Illinois) the Endeavor stent is coated with phosphorylcholine, a polymer licensed from Biocompatibles International (Oxford, UK) that is designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane.

• Medtronic Sofamor Danek (Memphis, Tennessee) reported U.S. market availability of the Vertex MAX Reconstruction System. The system of multi-axial screws, rods, hooks and connecting components assists in stabilizing the cervical and upper thoracic spine during spinal fusion surgery. The Vertex MAX Reconstruction System is indicated for use in cases of degenerative disc disease, spinal stenosis (narrowing of the spinal canal), spondylolithesis (forward shifting of vertebra position), fracture, dislocation, tumors and failed previous fusions. In the surgical procedure, a surgeon enters through the back of the patient’s neck and uses the titanium rods, multi-axial screws and hooks of the Vertex MAX Reconstruction System to stabilize the cervical and upper thoracic spine. The stabilization helps encourage fusion. To facilitate use, the system features top-loading screws with greater flexibility in screw placement, self-tapping screws that eliminate an operational procedural step, rotating saddles that reduce rod contouring and color-coded instrumentation that corresponds with the appropriate implant.

• OmniGuide (Cambridge, Massachusetts) has moved one step closer to gaining surgical experience at the University of Texas M.D. Anderson Cancer Center (Houston) with its OmniGuide Fiber in head and neck surgeries, toward the goal of having those findings published. Head and neck surgeries are the first indication OmniGuide is pursuing in its strategy to commercialize the OmniGuide Fiber, which is a hollow-core bandgap fiber for delivery of CO₂ laser energy, the company said. Although CO₂ lasers have been around since 1972, that technology does have limitations, said Gil Shapira, director of marketing and business development at OmniGuide. “The problem with the CO₂ lasers up until now for those 30 years is that there is no fiber to deliver them through,” Shapira said. “They have been used in the operating room through line-of-sight cutting. They’re hooked up to a microscope that’s outside the body of the patient.” Because a surgeon cannot insert the laser into the body with traditional CO₂ lasers, they are limited to dermatology use and laryngology. Shapira said the OmniGuide Fiber “enables the use of those lasers in any part of the body.” And while OmniGuide secured FDA clearance for the device in May for multiple indications, the company is initially focused on head and neck surgeries. The system is cleared for incision, excision, ablation, vaporization and coagulation of soft body tissues, including intraoral uses, in a variety of medical specialties. Those include general and plastic surgery, oral/maxillofacial surgery; dentistry, dermatology, endoscopic and open surgical procedures related to gynecology, otorhinolaryngology, gastroenterology, neurosurgery and pulmonary surgery for surgical and aesthetic applications.

• Quidel (San Diego) reported entering the rapid test market for determining the presence of blood in stool specimens as an aid in colorectal cancer screening. It has acquired the immunochemical Fecal Occult Blood Test (iFOBT) from Alfa Scientific Designs (Poway, California). The FDA-cleared and CLIA-waived test will be marketed to healthcare professionals as the QuickVue iFOB test. Quidel said the immunochemical fecal occult blood test category represents a large market opportunity, with more than 50 million fecal occult blood tests sold annually through medical/surgical distributors in the U.S. alone. It noted that Medicare reimbursement rates awarded immunochemical fecal occult blood tests over Guaiac-based fecal occult blood tests are significantly higher, since they have no dietary or medicinal restrictions and exhibit higher clinical sensitivity. The American Cancer Society recommends an annual fecal occult blood test for persons aged 50 and older to assist in the early detection of colorectal cancer.

• The Sigma division of Sigma-Aldrich (St. Louis) said the U.S. Patent and Trademark Office has granted the company U.S. patent No. 6,942,964, titled “Tracer Reagents that Enhance Reaction-Product Analysis,” covering the array of direct-load RED enzymes already being offered in Sigma’s polymerase chain reaction (PCR) product line. REDTaq products are a blend of various DNA polymerases combined with an inert red dye that allows quick visual confirmation of enzyme addition and reaction homogeneity, according to the company. The sample also can be loaded directly onto an agarose gel for electrophoresis following PCR. The red dye has no effect on downstream applications, Sigma said.

• Spectranetics (Colorado Springs, Colorado) said it will extend features of the recently launched 2.5 Turbo product to its entire CLiRpath product line used for clearing arterial blockages in the leg. Spectranetics has received 510(k) clearance from the FDA for the “continuous on” lasing train to be added to the CliRpath product line. The company said it plans to launch the expanded CliRpath Turbo product line within the next 90 days, allowing for required software upgrades to be completed for its customers. Spectranetics said many patients suffering from peripheral vascular disease and critical limb ischemia have total occlusions that cannot be crossed with standard guidewires, and have so few treatment options that surgery – either bypass or limb amputation – is nearly inevitable. It said its CLiRpath (Cool Laser Revascularization for Peripheral Artery Therapy) product line provides an alternative in the fight against amputation.

• St. Jude Medical (St. Paul, Minnesota) demonstrated a range of cardiac surgery products – including new valve replacement and repair products and advanced beating-heart cardiac tissue ablation technology – at the European Association of Cardio-thoracic Surgeons (EACTS) meeting, in Barcelona, Spain. The company began the European launch of its Epicor Cardiac Ablation System at EACTS. The system features a high-intensity focused ultrasound en-ergy source, which enables physicians to create continuous transmural ablative lesions safely and reproducibly, without the need to put patients on a heart-lung bypass machine. Results of a prospective multi-center study using the Epicor Cardiac Ablation System showed that at six-month follow-up, 85% of patients in the study group remained free from atrial fibrillation. The St. Jude Medical Rigid Saddle Annuloplasty Ring also was introduced at EACTS. The device is the only annuloplasty ring designed to approximate the mitral valve’s natural, 3-D saddle shape, resulting in less stress on the valve’s leaflets and chords.

• Tm Bioscience (Toronto) said that Genzyme Genetics, a provider of complex diagnostic testing services, has launched its upgraded CFplus cystic fibrosis mutation analysis, which now includes testing for 97 mutations. The CFplus assay incorporates technology from Tm Bioscience that was developed in a collaborative effort. “Our collaboration with Genzyme Genetics has produced one of the most innovative and technically advanced products available in the area of molecular diagnostics, made possible through our Tag-It platform,” said Greg Hines, president and CEO of Tm Bioscience, a company whose product menu is focused in the fields of human genetic disorders, pharmacogenetics and infectious disease.

• Vascular Solutions (Minneapolis) said it has received 510(k) clearance from the FDA for the launch of its next-generation V3 version of the Pronto extraction catheter. The Pronto extraction catheter is clinically used for the percutaneous removal of soft thrombus from vessels in the arterial system. The new V3 version incorporates a fully braided construction, hydrophilic coating and a consistently large extraction lumen, all advances from the original Pronto catheter that was launched in the U.S. in January 2004. The Pronto consists of an extraction catheter with a proprietary atraumatic distal tip and large extraction lumen that can be percutaneously inserted into arteries to remove soft thrombus. The Pronto extraction catheter was initially developed by Dr. Pedro Silva of Milan, Italy, who exclusively licensed the design to Vascular Solutions.

• VNUS Medical Technologies (San Jose, California) said that five-year follow-up results on the VNUS Closure procedure have been published in the September issue of the Journal of Vascular Surgery. The VNUS Closure procedure is an endovenous radiofrequency treatment of venous reflux that uses a small catheter to close diseased veins in the legs, allowing blood to reroute to other healthy veins. Venous reflux disease often is an underlying cause varicose veins. The journal article, authored by Robert Merchant, MD, Olivier Pichot, MD, et al., reported results from a large multi-center international registry indicating that the VNUS Closure procedure exhibits long-term enduring efficacy and persistent patient symptom relief. Of 1,222 limbs treated, 87% of veins evaluated at five-year follow-up remained closed. Prior to treatment, 85% of patients experienced limb pain, whereas just 10% experienced pain six months after treatment and 8.5% at five years, according to the report. The company said the report also demonstrated that the VNUS Closure procedure has been used in small saphenous and accessory saphenous veins, in addition to great saphenous vein treatment. The VNUS Closure System has treated more than 100,000 pati-ents since 1999.