In what could mark a new era in sterilization procedures for women, Conceptus (San Carlos, California) received FDA approval last month for its Essure Permanent Sterilization system. Essure offers a less-invasive alternative to tubal ligation, with the company — and the women's healthcare sector in general — projecting a large shift away from that procedure for permanent birth control, undergone by an estimated 700,000 women annually in the U.S. At the same time, it offers an obvious alternative to vasectomy as well.

Tubal ligation requires general anesthesia and the creation of incisions. Recovery averages about three days and may take up to 10 days. Essure requires no incision and only local anesthetic. The device, which is essentially a tiny dacron coil, is delivered into the uterus via hysteroscope and inserted into the end of the fallopian tube to produce a sort of "plug," created via the fallopian tissue itself. Patients are conscious throughout the procedure and most return to normal activity or work within a day after the procedure, according to company statistics.

Steven Bacich, president and CEO of Conceptus, said that the company initially is targeting three markets in the U.S.: those women who would ordinarily receive tubal ligation, a group of more than 7 million women who have two or more children and are seeking permanent contraception, and the vasectomy market on the male side.

A key advantage for Conceptus is early dominance with its technology, according to Bacich. "There are no other competitors in human clinical trials," he said. "They may be out there, but they haven't emerged to date."

Overall, Essure has posted a success rate of more than 99%, thus comparing extremely well with other contraceptive methods with success rates ranging from a low of 93% to the best rate of about 99%, according to the company.

Uptake of the Essure device will be facilitated by the existence of a reimbursement code already in place, according to Glen Furuta, Conceptus CFO.

Elsewhere in the product pipeline:

Advanced Cochlear Systems (ACS; Snoqualmie, Washington) said it has received a notice of allowance from the U.S. Patent and Trademark Office for its patent titled "A Method for the Real-Time Transformation of an Electrical Signal Representative of a Waveform." The patent will protect ACS technology enabling different sound frequencies to stimulate distinct regions of the cochlea in a way that mimics natural hearing more closely than cochlear implants currently on the market. The technology also is designed to preserve the exact timing of sound waves, providing the foundation for the development of binaural cochlear implants.

American Medical Alert (AMAC; Oceanside, New York), a national provider of personal emergency response systems (PERS) and 24-hour monitoring services, and Health Hero Network (Mountain View, California), the developer of technology solutions for health monitoring, released PERS Buddy. The interactive monitoring system combines AMAC's personal emergency response technology with Health Hero Network's Health Buddy appliance, using its technology platform to ensure secure data management and healthcare provider access to patient data across an Internet connection. PERS Buddy is the first product to combine access to emergency care with ongoing health monitoring for over a dozen medical conditions to increase a healthcare provider's ability to monitor patients at home, the company said.

Biomet (Warsaw, Indiana) said the FDA cleared its RingLoc constrained hip liners used in revision hip procedures. The polyurethane liners are used in conjunction with metal-backed acetabular shells and are intended for use in primary or revision procedures in patients with a high risk of hip dislocation. The company said it expects to begin shipping RingLoc liners in the next few days. Biomet and its subsidiaries manufacture products used primarily by musculoskeletal medical specialists in both surgical and non-surgical therapy.

Cambridge Scientific (CSI; Cambridge, Massachusetts) reported results for its lead spinal research product, the Wisorb Spinal Fusion System. A recent article in the journal Spine, "Biomechanical Analysis of Biodegradable Interbody Fusion Cages Augmented with Poly(Propylene Glycol-co-Fumaric Acid)," demonstrated that the Wisorb Spinal Fusion System is mechanically comparable to bone in an interbody fusion model. CSI's Wisorb device reduces the risk of clinical complications by mirroring both mechanical properties and composition of vertebral bone, the company said. Frank Kandziora, MD, at the Charite University Medical Center (Berlin, Germany) and a CSI collaborator, saw an immediate application for his clinic patients: "Biodegradable cages will be able to increase the clinical outcome of our patients significantly by eliminating the disadvantages and complications associated with metallic cages." The Spine study compared traditional titanium, allograft and biodegradable polymeric cages with and without a proprietary Dontex scaffold to determine stiffness and failure load of the L4/5 motion segment in 48 cadaveric spines. The Wisorb devices showed mechanical properties at least as good as those of the allograft cages and, when combined with the Dontex scaffold, the Wisorb cage resulted in higher stiffness and comparable failure load to titanium cages.

Computer Motion (Santa Barbara, California), a developer of robotic surgical systems, said Health Canada granted Class IV clearance for the Zeus Surgical System and accessories for sale and use within Canada. The company may now market the Zeus System for sale in Canada for cardiac surgery and for telesurgery applications. The Zeus System received Class III clearance earlier in 2002. Mehran Anvari, MD, director of the Center for Minimal Access Surgery at St. Joseph's Healthcare (Hamilton, Ontario), said, "The promise of advanced research into telemedicine and telesurgery is the ability for physicians to deliver the same standard of high-quality healthcare to any person, regardless of their location. We hope that the success of our efforts in this regard will remove the barriers of time and distance from the delivery of needed care to every patient in Canada."

CryoCath Technologies (Montreal, Quebec), which focuses on cryotherapy products to treat cardiovascular disease, submitted to the FDA the fifth and final module in the company's PMA filing plan for the Freezor Cardiac Cryoablation System. The module presents clinical results of the company's 165 patient pivotal FROSTY trial, which was designed to determine Freezor's safety and effectiveness in treating supraventricular tachycardia (SVT). The results of the FROSTY trial are expected to be released upon completion of the FDA review process. "Today's announcement keeps us on plan to launch Freezor into the U.S. marketplace within 12 months," said Steven Arless, president and CEO of CryoCath. Freezor is a single-use, minimally invasive cryoablation catheter specifically designed to create focal lesions to treat high-risk arrhythmias near the AV node where precision is of critical importance. Freezor can reach temperatures at its tip as low as -80 degrees C inside a beating heart.

Elbit Medical Imaging (EMI; Tel Aviv, Israel) said that its InSightec joint venture has received CE mark certification for its ExAblate 2000 Focused Ultrasound Therapy Device for the treatment of uterine fibroids. The regulatory approval allows the commercial use of the device in European Union countries, as well as Switzerland, Norway, Iceland and Liechtenstein. The company said ExAblate 2000 is based on technology that combines high-intensity focused ultrasound with magnetic resonance imaging, designed to achieve destruction of tumors in a non-invasive manner and under real-time imaging control. EMI indirectly holds a 61.3% interest and GE Medical Systems (Waukesha, Wisconsin) holds 16.8% interest in InSightec.

Eunoe (Redwood City, California) has received CE mark approval for its CogniShunt system for the treatment of Alzheimer's disease (AD). Eunoe also has received ISO 9001/EN 46001 registration from the British Standards Institute, a European Union notified body. The registration signifies the company's compliance to international standards for quality in the design, development and manufacturing of neuroscience medical devices. Eunoe is conducting a national, multi-center, Phase III study under an FDA investigational device exemption to support the approval of the CogniShunt for patients with AD in the U.S. The CogniShunt System is an implantable device designed specifically to treat patients with adult onset dementia. It is designed to increase the flow of cerebrospinal fluid (CSF) and improve clearance of neurotoxins from the CSF that are believed to contribute to the progression of Alzheimer's disease.

Guidant (Indianapolis, Indiana) said a premarket approval application was submitted to the FDA for the investigational Multi-Link Vision Coronary Stent System, the company's seventh-generation Multi-Link stent platform for the treatment of coronary artery disease. The Multi-Link system is constructed of a cobalt chromium alloy, enabling the stent to have thinner stent struts and enhanced deliverability while maintaining radial strength and visibility, the company said. "As evidenced by the data presented at TCT [Transcatheter Cardiovascular Therapeutics 2002] in September, the Multi-Link Vision Stent System registry has demonstrated excellent angiographic binary in-segment restenosis rates of 16.7% and target vessel failure rate of 6.7%," said Dean Kereiakes, of Christ Hospital (Cincinnati, Ohio) a principal investigator for Guidant's Multi-Link Vision registry. Guidant said it plans to use cobalt chromium stents in future drug-eluting stent platforms.

HydroCision (Andover, Massachusetts) said the FDA has granted 510(k) clearance to market its fluidjet-based hydrosurgery system for open and arthroscopic spinal surgeries. This regulatory clearance follows prior CE mark certification. The fluidjet-based hydrosurgery system is designed to enable spine surgeons to cut and remove soft tissue, ablate and shape hard tissue or bone more precisely and rapidly than they can with current techniques. The system also will avoid the collateral trauma associated with other surgical modalities, the company said. "It will be our third market entry and is a great complement to the ExoJet Tissue Resection System for arthroscopic joint procedures and the VersaJet Hydrosurgery System for surgical debridement," said President Doug Daniels.

Inspeck (Montreal, Quebec), which is focused on 3-D healthcare solutions, introduced the BFD (for breast and face digitizer) 1300 imaging system, which specializes in face and torso plastic surgery communication, simulation and quantification in 3-D to assist surgeons in their interaction with their patients. Earle Hall, company president, said, "The BFD 1300 will give doctors and patients a more realistic and natural way to communicate by presenting real-life three dimensional imagery." The BFD 1300 will enable surgeons to quantify the topography of a patient's body surface, communicate with their patients using 3-D images and simulate the surgery's results. The company said the BFD 1300 is making its mark because of its ease-of-use, affordability, capture speed and capacity to precisely measure a patient's skin texture and body geometry.

Isotechnika (Edmonton, Alberta) said its wholly owned diagnostics division, Isodiagnostika, was issued two U.S. patents relating to its diagnostic test, Diatest. U.S. patent No. 6,461,870 relates to a C13 glucose breath test for the diagnosis of diabetic conditions and monitoring glycemic control, while patent No. 6,468,802 relates to the test kit necessary to perform the test. "This test is a diagnostic for determining not only diabetes but insulin resistance. Monitoring insulin resistance levels is important as a precursor to diabetes. Such a test will provide physicians with a tool in determining not only if a patient is diabetic, but whether that patient may be predisposed to diabetes," said Robert Foster, chairman and CEO.

Karl Storz Endoscopy-America (Culver City, California), which focuses on diagnostic and operative endoscope technology, unveiled the 4mm Bettocchi Hysteroscope System with a 5 Fr (1.67mm) operating channel. Using 2mm Hopkins II rod lens technology, the new 4 mm system provides brilliant and clear visualization of the entire uterine cavity. The new 2 mm optical system provides minimally invasive uterine access, allowing the use of both 3.6 mm diagnostic continuous flow sheaths and 4.2mm therapeutic sheaths. Karl Storz Endoscopy-America is an affiliate of Karl Storz GmbH & Co. KG (Tuttlingen, Germany).

Kinetic Concepts (KCI; San Antonio, Texas) reported a new model of its Vacuum Assisted Closure (V.A.C.). The new product, the V.A.C. Freedom system, was showcased at the National Association for Home Care's annual meeting in Salt Lake City, Utah. The V.A.C. Freedom system enables patients to return to work and daily activities, the company said. At just over 3 1/2 pounds, the system can be worn in its carrying case over the shoulder or around the waist. The V.A.C. Freedom system also has an on-screen help guide for users and features a canister with 300 ml of volume, which allows for fewer changes.

A new non-invasive low-level laser called the ML830, distributed by Laser Therapeutic Technology (Ocean Grove, New Jersey) has received FDA market clearance. Its use is designed to improve the symptoms of carpal tunnel syndrome reducing the need for surgery, the company said. The ML830 Laser is a non-thermal laser capable of penetrating deep into tissue. Once delivered, the light energy promotes the process of photobiostimulation resulting in a reduction in pain, inflammation, edema and an overall reduction in healing time, the company said. The laser is a portable, hand-held, battery-operated low-level energy laser. Treatments typically last 15 to 20 minutes and are delivered three times a week over a five-week period.

Lumenis (Yokneam, Israel) said the FDA has granted 510(k) clearance to the first application-guided pulsed CO₂ laser, the UltraPulse SurgiTouch. The UltraPulse SurgiTouch is the first pulsed CO₂ laser to offer an intuitive, versatile interface featuring pre-set parameters by specialty, application and suggested delivery device, the company said. Clinical indications include surgical applications in otorhinolaryngology, gynecology, aesthetic, neurosurgery, podiatry, orthopedic, general surgery, thoracic surgery, arthroscopy, dental and oral surgery and genitourinary. Robert Grant, executive vice president of Lumenis, said, "The laser system will be the first to result from the combined R&D advances of the two companies — Coherent Medical Group and ESC Sharplan — which last year merged to form Lumenis. The innovative blending of the pulsed radio-frequency excited CO₂ laser technology of the UltraPulse from Coherent and the advanced scanning capability of the ESC Sharplan SurgiTouch takes CO₂ laser surgery to new heights." Lumenis also received marketing clearance from the FDA for the ReLume Repigmentation Phototherapy System for the treatment of leukoderma, or the loss of skin pigmentation. For stretch marks, acne scars, post-surgical and traumatic scars, burns and laser-resurfaced or chemically peeled skin, lost pigment now can be restored with the ReLume system, the company said. It was launched at the American Society of Dermatologic Surgeons meeting in Chicago, Illinois.

Misonix (Farmingdale, New York) and Focus Surgery (FSI; Indianapolis, Indiana) said Focus has submitted the final documents to the FDA for a premarket approval application to market the Sonablate 500 for the treatment of benign prostatic hyperplasia. The submission includes data on the treatment of 68 men at five sites across the U.S. Misonix currently owns approximately 20% of Focus Surgery and has the right to produce its products. The Sonablate 500 system was developed by Focus and is manufactured by Misonix in Farmingdale. It performs both prostate imaging and treatment using ultrasound. Using FSI's ultrasound transducer technology, the SB-500 performs diagnostic level imaging of the prostate and performs minimally invasive image-guided treatment of both benign and cancerous prostate tissue using high-intensity focused ultrasound. Misonix also said that Focus Surgery released "outstanding" interim results for the treatment of prostate cancer using the Sonablate HIFU device. Results have been obtained in both Japanese clinical trials of about 100 patients at 10 locations, and 15 patients in the U.S. clinical trials at the Indiana University School of Medicine (Indianapolis, Indiana). Misonix currently owns about 20% of Focus and has the right to produce its products. The Sonablate system is capable of killing deep-seated cancer tissue by elevating the temperature in a focal zone, without affecting the intervening tissue, and without side effects such as ionization or radiation, the company said. The treatment is guided by ultrasound imaging that also combines HIFU technology.

Non-Invasive Monitoring Systems (North Bay Village, Florida) released results of a study showing that the acceleration therapeutics AT101 may be a superior method of cardiopulmonary resuscitation when compared to traditional methods. The AT101 is a platform mounted on a hospital-like patient gurney that moves repetitively in a back-and-forth motion from head to foot. CPR administered by the AT101 produced a full recovery, the company said, without adverse events such as rib fractures that can occur with traditional CPR.

PerkinElmer Life Sciences (Boston, Massachusetts), a provider of drug discovery, life science research and genetic disease screening solutions, reported the commercial availability of Lutetium-177 (Lu-177), a radioisotope being investigated for use in the radiotherapeutic treatment of cancers such as breast, prostate, colon and brain. PerkinElmer Life Sciences said it will become the first company to offer Lu-177 with worldwide distribution capabilities. PerkinElmer also reported its introduction of a new generation microarray informatics solution to automate integrated data management from microarray spotters, scanners and gene expression data analysis. The software automates data flow from SpotArray 24 or SpotArray 72 microarray printers and the ScanArray Express family of microarray scanners.

Scion Cardio-Vascular (Miami, Florida) has received CE marking for its Clo-Sur P.A.D. hemostasis device. The Clo-Sur P.A.D. is a topical, non-invasive device used for rapid control of bleeding associated with catheter removal following a catheterization procedure such as coronary stenting. The Clo-Sur P.A.D. accelerates the hemostasis process in conjunction with placing pressure on the puncture site. Scion CV's Clo-Sur P.A.D technology employs a foam pad featuring the company's proprietary polymer Polyprolate and is water soluble.

Smith & Nephew Endoscopy Division (Andover, Massachusetts), a subsidiary of Smith & Nephew (London), introduced the Smith & Nephew Decompression Catheter, an ElectroThermal or heat-based procedure for lower back and leg pain associated with bulging or contained herniated discs. It is prescribed for symptomatic patients who have failed conservative treatments.

Spire (Bedford, Massachusetts) said that Spire Biomedical, its wholly owned subsidiary, has received 510(k) clearance from the FDA to market the Pourchez RetrO separated-tip hemodialysis catheter. Spire Biomedical entered the dialysis catheter market earlier this year with the introduction of the Pourchez XpressO catheter. The catheter will be distributed though Spire Biomedical's existing nationwide network of specialty distributors and will be available to physicians shortly, the company said.

The Auto Suture Division of United States Surgical (Norwalk, Connecticut), a division of Tyco Healthcare, said it will offer surgical access port products featuring VersaSeal Plus technology, a seal system providing surgeons with a range of benefits, the company said. A universal seal that self-adjusts to accept 4.5 mm to 12 mm instruments without external converters, VersaSeal Plus provides hands free exchange of instruments and has been shown to be extremely durable. The design of VersaSeal Plus was designed to minimize the potential for tears or leakage during instrument insertion or manipulation and to offer surgeons improved tactile feel and more precise movement, the company said.

Zimmer Holdings (Warsaw, Indiana) launched the NexGen Rotating Hinge Knee, another option for orthopedic surgeons to use in addressing difficult primary and revision knee cases. In primary knee replacement, the patient's own ligaments may provide sufficient constraint to keep the implant components in proper alignment. The NexGen Rotating Hinge Knee is intended for use in knees that have experienced moderate to severe knee instability, significant bone loss or have ligament deficiencies. Zimmer said the NexGen Rotating Hinge Knee is being launched simultaneously in North America and Europe and will be available globally by early 2003.