Spectranetics (Colorado Springs, Colorado) has demonstrated that a company can work with the FDA and win a product approval, even over a resounding turndown by one of the agency's advisory panels. The company last month reported FDA clearance of its excimer laser system, the CliRpath, for treatment of total occlusions of the leg arteries this despite last fall's seemingly decisive 9-1 vote by the Circulatory System Devices panel against recommending approval of the indication.

That vote was followed by a meeting between Spectranetics and the agency in mid-November, resulting in two revisions in the regulatory path, key changes that produced approval for the application sought, according to company President and Chief Executive Officer John Shulte. One change was a revision of the particular patient group being analyzed, and the other was in the regulatory filing - from a premarket approval supplement to a 510(k), Shulte told The BBI Newsletter.

While acknowledging the heavy panel vote against the application, Shulte noted, however, that there was clear panel consensus on the system's safety. Additionally, he said that five of the panel members had cast their votes against approval "with great angst and they told us, 'We really think you have great clinical results and the product is very safe.'"

The critical hang-up, he said, was that Spectranetics' clinical data did not convince panelists that the use of a laser to remove arterial occlusions in the legs was superior to the traditional standards of treatment use of a balloon and stenting, or arterial bypass strategies essentially paralleling the use of angioplasty or bypass surgery in treating blockages near the heart. But Shulte said there was an alternative way of looking at the company's data, largely compiled from its Laser Angioplasty for Critical limb Ischemia (LACI) trial. That alternate route was found in the perception that "20% of patients [in the trial] had total occlusions."

Spectranetics reported the first successful CLiRpath procedures, performed by Craig Walker, MD, Mohammed Khan, MD, and David Allie, MD, at Cardiovascular Institute of the South (Houma, Louisiana) and John Laird, MD, at the Washington Hospital Center (Washington). The physicians used the 2.3 mm and 2.5 mm CLiRpath Catheters. Laird was principal investigator of the LACI trial. Allie and Walker were principal investigators in the Louisiana LACI Case Series. Laird used a 2.3 mm CLiRpath Catheter to recanalize a 30 cm occlusion in the superficial femoral artery in a patient with an ischemic ulcer. After successful laser atherectomy, balloon angioplasty was performed without the need for a stent.

Elsewhere in the product pipeline:

Advanced Medical Optics (AMO; Santa Ana, California), a maker of ophthalmic surgical devices and eyecare products, and Ophtec USA (Boca Raton, Florida), a privately held subsidiary of Ophtec BV (Groningen, the Netherlands), reported that they have secured approval of the StabilEyes capsular tension ring (CTR). With the FDA approval, AMO, which is the sales and marketing distributor of the product, will begin marketing activities throughout North America. Ophtec has been manufacturing CTRs, which hold an intraocular lens in place in the capsular bag of the eye, under the Oculaid brand name outside the U.S. for more than 10 years. It began investigational studies in the U.S. in 2001 and was granted expedited review status by the FDA in September. The CTR is a "uniplanar, 270-degree, semicircular ring that is made of polymethylmethacrylate, which absorbs ultraviolet light. It has one "manipulation eyelet" at each end of the semicircle ring. is designed to be permanently implanted into the human capsular bag in the eye during cataract removal surgery.

AGA Medical (Minneapolis, Minnesota) has received FDA clearance for its Amplatzer Vascular Plug, an implantable device that provides physicians with a minimally invasive alternative to current options for correcting common vascular disorders. The approved application is to occlude specifically targeted veins and arteries for cases where the site to be treated is within the peripheral vasculature. The Amplatzer Vascular Plug is introduced to the target vessel via a catheter threaded through a vein or artery, accessed via a small incision in the patient's groin. The plug can be placed or repositioned, if necessary, and finally released in a precise manner. The self-expandable, cylindrical device is made of super-elastic Nitinol-wire mesh in diameters ranging from 4 mm to 16 mm. The device is non-magnetic and therefore compatible with magnetic resonance imaging technology.

Alaris Medical Systems (San Diego, California) has introduced in Europe a next-generation syringe pump featuring a standalone design and embedded software incorporating drug models for intravenous anesthesia. The compact design of the new Asena PK Syringe Pump enables it to be moved easily while remaining connected to a patient. This feature safeguards against the loss of vital patient data and, combined with the embedded software drug models, helps assure the safe, precise delivery of anesthesia drugs. The Asena PK Syringe Pump software includes pharmacokinetic and pharmacodynamic modeling for three widely used anesthesia drugs.

Alcon (Fort Worth, Texas) reported updated clinical results on the AcrySof ReSTOR intraocular lens (IOL) that demonstrate its ability to substantially restore a cataract patient's ability to see both near and distant objects without the aid of reading glasses or bifocals. In the study, 99% of patients who received the AcrySof ReSTOR and 98% of patients who received the monofocal IOL achieved distance visual acuity of 20/40 or better, without correction by contacts or glasses, with both groups exceeding the FDA grid value of 92% for this measurement. Following bilateral implantation, 74% of patients receiving the AcrySof ReSTOR achieved near visual acuity of 20/25 or better without correction by contacts or glasses, while only 14% of the monofocal control group achieved this level.

American Medical Systems Holdings (Minnetonka, Minnesota) reported that its Apogee System has received FDA clearance. Apogee is a minimally invasive system designed for repairing vaginal vault prolapse using the IntePro or InteXen graft material. The Apogee system is designed to deliver better outcomes than traditional abdominal or laparoscopic techniques, the company said. The company said it would begin physician training in preparation for commercial release later this year.

BD (Becton, Dickinson and Co.; Franklin Lakes, New Jersey) said it is now offering the BD Sharps Disposal By Mail system, a method for home sharps disposal that helps protect against possible injury or infection. The BD Sharps Disposal By Mail system available at pharmacies includes a BD Home Sharps Container, postage-paid return box made of heavy-corrugated cardboard and additional packaging materials to safely send the filled sharps container through the mail. The container will then be destroyed at a certified incineration facility. The system meets the new EPA recommendations for home sharps disposal, as well as federal safety and postal guidelines, BD said.

BSD Medical (Salt Lake City, California) said the FDA has granted the company an investigational device exemption approval for a new applicator used with the BSD-2000 Regional Hyperthermia System, a system it expects to launch in the U.S. in the near future for the treatment of tumors The new applicator, called the Sigma Ellipse, uses an array of antennae surrounding the patient to focus microwave energy on cancerous tissues located deep in the body such as ovarian, prostate, bladder, cervical and colon cancers and raise them to what the company calls "fever-level temperatures," about 106 degrees F. The patient lies in a prone position and the applicator can be moved along his/her body to the ideal position for focusing on the cancer. The Sigma Ellipse applicator is an improved design of the Sigma-60 applicator, which already has been used in numerous clinical trials. BSD said the FDA accepted the new Sigma Ellipse as a developmental packaging change in the Sigma-60 applicator.

Caliper Life Sciences (Hopkinton, Massachusetts) has started shipping the protein assay for its LabChip 90 Automated Electrophoresis System. The new assay is an alternative to the conventional method for sizing and quantification of proteins (SDS-PAGE). Capable of automated sampling from 96-well microtiter plates, the company said the LabChip 90 system particularly benefits laboratories for which labor is in short supply. The LabChip 90 system also is capable of automated analysis of DNA samples. By simply switching the microfluidic chip and reagents, customers can change between the DNA and protein applications in minutes.

Cardima (Fremont, California) said doctors at Lenox Hill Hospital (New York) reported two successful less-invasive cases using its Surgical Ablation System (SAS) to treat atrial fibrillation (AF). The SAS ablates cardiac tissue during heart surgery using radiofrequency energy. The SAS technology was applied in two AF cases during a mini-thoracotomy, or less invasive approach.

CryoCath Technologies (Montreal, Quebec) received 510(k) clearance last month from the FDA for FrostByte, a clamp ablation device to be used in the treatment of cardiac arrhythmias. The company expects to receive CE Mark shortly, and launch the product in June. Steve Arless, president and chief executive officer, described the FrostByte as the next generation of the company's SurgiFrost system. "We extended the cooling section by 25% to make longer lesions more quickly and we've also built it into a clamp device." He said cryotherapy is "the preferred energy source for the surgical ablation of cardiac arrhythmias, and currently a clamp system is the most popular approach to ablate atrial tissue."

CryoLife (Kennesaw, Georgia) reported FDA approval of a new disposable delivery system for BioGlue Surgical Adhesive. The BioGlue Syringe provides surgeons with an effective adhesive in an easier-to-use, self-contained, disposable syringe. The BioGlue Syringe will be available in 2 ml and 5 ml volumes.

Digene (Gaithersburg, Maryland) reported FDA approval of its Rapid Capture System application that allows high-throughput testing with the company's hc2 High-Risk HPV DNA Test. Using this system, 352 patient specimens can be analyzed by one technologist in a 6.5-hour lab shift. Digene's test is approved by the FDA to detect high-risk HPV as part of routine cervical cancer screening, in conjunction with a Pap test in women age 30 and older (marketed as the DNAwithPap Test). It also is approved for follow-up evaluation of an inconclusive Pap result in women of any age.

Through its Health Imaging Group, Eastman Kodak (Rochester, New York) reported a new option for its Kodak Directview DR 9000 digital radiography (DR) system that enables trauma centers to accelerate treatment and improve care while minimizing the movement of critically injured patients. The trans-bay option involves installing overhead rails up to 30 feet long so the Kodak DR system can move to as many as three different patient locations in rapid succession. The company said the trans-bay application can improve patient care by minimizing the movement of seriously ill or injured patients. The Directview DR 9000 system features a U-arm design with a full range of motion that offers flexibility for chest, extremity, skull, abdominal and trauma exams.

ELA Medical (Milan, Italy), a Sorin Group company, said it has launched in Europe the Alto 2 MSP 627 cardiac resynchronization therapy defibrillator. The Alto 2 MSP system incorporates the latest therapies for heart failure patients and for sudden cardiac death prevention, including ELA's PARAD/PARAD+ arrhythmia discrimination that identifies and analyzes complex arrhythmias; fully configurable biventricular function with programmable ventricle-to-ventricle delay and independent left ventricular output; rate-responsive biventricular and flexible pacing into tachycardia detection zones; right ventricular sensing along with complete diagnostics and advanced follow-up tools.

Endologix (Irvine, California) reported details of its U.S. pivotal trial with the PowerLink system endoluminal stent graft (ELG) for the minimally invasive treatment of abdominal aortic aneurysms. Results of the trial were presented at the Eastern Vascular Society meeting in Philadelphia, Pennsylvania. The pivotal trial enrolled 193 test patients and 66 controls treated by conventional surgery. Among other results, the study demonstrated that the PowerLink System was successfully deployed in 97.9% of test patients; and operative times, ICU time, blood loss and hospital length-of-stay for PowerLink System patients was significantly lower vs. control patients.

Escalon Medical (Wayne, Pennsylvania) said its Sonomed division introduced two new products at the American Society of Cataract & Refractive Surgery symposium and congress in San Diego, California. The UBM/35S is a high-frequency ultrasound bio-microscope that features a miniature lightweight probe, an interchangeable 35 MHz or 50 MHz transducer, providing an accurate image of the front of the eye. The other product, E-Z Scan, is an enhanced combination A-scan/B-scan ophthalmic ultrasound device used to image and diagnose retinal and other conditions at the back of the eye. Escalon has received FDA marketing clearance for its E-Z Scan and said it is launching this product in the U.S.

Genzyme (Cambridge, Massachusetts) said clinical data were reported that show Seprafilm Adhesion Barrier to be effective in reducing the incidence of adhesive small bowel obstruction following colorectal surgery. The data were presented at the annual meeting of the American Society of Colon and Rectal Surgeons in Dallas, Texas, and come from a five-year multi-center study involving nearly 1,800 patients. Seprafilm is a temporary, physical adhesion barrier for abdominal and pelvic adhesion prevention.

Building on the success of its Bod Pod system an egg-shaped, futuristic-looking device for providing a fat/muscle index for adults Life Measurement (Concord, California) has introduced the Pea Pod, a smaller version for infants. The Pea Pod, FDA-cleared in March, is the only device on the market that has successfully applied gas laws to non-invasively measure volumes in infants, according to the company.

A high-speed flow cytometry system for cervical cancer screening that was born from a deal almost two years ago is coming closer to fruition. In what Matritech (Newton, Massachusetts) President and Chief Operating Officer David Corbet called "the first substantive" news to be released since the deal forming a partnership with Sysmex (Kobe, Japan) was reported in November 2002, the companies last month revealed that they are doing a study on 10,000 samples from women either at risk or who have cervical cancer. Those samples will be compared to the traditional Pap smear method, whereby the cervical cells are placed on a slide an manually studied for evidence of cancer. The new system hinges on Matritech's NMP (Nuclear Matrix Protein) 179, which Corbet said "appears in virtually all dysplastic cervical calls," or precancerous cells. Sysmex is building an imaging flow cytometer using a liquid Pap smear that has been treated with NMP antibodies, so that the bad cells or the dysplastic cells are lit up, Corbet told BBI.

Medical Services International (Edmonton, Alberta) said it has completed a major independent test of its VScan Tuberculosis (TB) rapid test kit in Europe. The test results showed that the VScan TB test kit had 100% specificity with 76% sensitivity. According to the company, there is no test currently available for TB that is as accurate as the VScan TB test kit, and it is the only test kit for TB that has no false positives. The VScan rapid test kit is a single-use test for screening of HIV 1&2 and subgroup O, hepatitis B&C, TB, dengue fever and West Nile virus.

Medtronic Sofamor Danek (Memphis, Tennessee) reported FDA approval of the use of Infuse Bone Graft in the treatment of acute, open fractures of the tibial shaft, a long bone in the lower leg. The approval broadens the indications for Infuse Bone Graft, a product that has been used since 2002 in spinal surgery with metallic cages. Infuse Bone Graft contains rhBMP-2/ACS (recombinant human Bone Morphogenetic Protein-2/Absorbable Collagen Sponge), a protein device that enhances bone healing discovered and developed by Wyeth (Madison, New Jersey). To use Infuse Bone Graft, surgeons reconstitute rhBMP-2 powder with sterile water and apply it to a collagen sponge that is placed over the fracture site after appropriate wound management and fracture stabilization with an intramedullary nail. The premarket approval application was originally submitted to the FDA by Wyeth and transferred to Medtronic immediately following FDA approval for this new indication.

Medtronic Physio-Control (Redmond, Washington) reported the global introduction of a new patient data transmission product upgrade for the Lifepak12 defibrillator/monitor. Equipped with Bluetooth SIG technology, Lifenet Blue allows emergency medical service (EMS) teams to wirelessly transfer patient data from a Lifepak 12 to a tablet PC running Lifenet EMS ePCR (electronic patient care report) to provide a complete pre-hospital patient record. Lifenet Blue provides EMS teams the ability to wirelessly transmit patient data from a Lifepak 12 defibrillator/monitor via a Bluetooth-enabled cell phone to a remote Lifenet RS Receiving Station in a hospital emergency department. Lifenet Blue sends information directly from the Lifepak 12 with no need for the user to purchase an iPAQ PC to assist in data transmission.

OmniSonics Medical Technologies (Wilmington, Massachusetts) reported that it has been granted two U.S. patents relating to its OmniWave Technology Platform. Patent No. 6,730,048, titled "Apparatus and method for ultrasonic medical device with improved visibility in imaging procedures," provides for a proprietary capability that allows an ultrasonic medical device to be guided and placed accurately during minimally invasive endovascular procedures to remove occlusions from blood vessels. Patent No. 6,733,451, titled "Apparatus and method for an ultrasonic probe used with a pharmacological agent," covers the use of an ultrasonic device with the delivery of agents that may, for example, further aid in the dissolution of occlusions.

Proxima Therapeutics (Alpharetta, Georgia) said that study results presented at the annual meeting of the American Brachytherapy Society in Barcelona, Spain, show that the MammoSite Radiation Therapy System is potentially a more efficient way to deliver a boost of radiation to a breast tumor site following whole breast external beam radiation. In the study, researchers compared MammoSite to electron radiotherapy, currently the method most often used to deliver a boost of radiation. The median amount of targeted tissue that received the prescribed radiation dose was 37.6% for patients who received electron boost radiotherapy. With MammoSite, that coverage was improved to 100%. Patients who were treated with MammoSite also had a significantly smaller amount of healthy tissue exposed unnecessarily to radiation than patients who were treated with electron radiotherapy. Proxima also reported that post-market data on its FDA-cleared GliaSite Radiation Therapy System also was presented at the meeting. The retrospective analysis of 80 patients with recurrent glioblastoma multiforme treated at nine U.S. medical centers found that patients who received radiation treatment internally with GliaSite following surgery had a median survival rate of more than 36 weeks.

Quest Diagnostics (Teterboro, New Jersey) reported that it is now offering a gene-based blood test to detect genetic mutations associated with congenital adrenal hyperplasia (CAH), a condition that causes females to accumulate male sex hormones. The new test, which is available to physicians nationwide, detects 90% to 95 % of genetic mutations associated with CAH. The test uses a gene-amplification procedure through which the 21-hydroxylase gene, a defective form of the gene on the same chromosome and products of recombination between those two genes are prepared for analysis by DNA mini-sequencing.

Rubicon Medical (Salt Lake City, Utah) reported completing the initial clinical testing of the Rubicon Filter in an enrollment of more than 30 human cases in its RULE-Carotid clinical study in Europe. The RULE-Carotid study involved the testing of the Rubicon Filter in the carotid arteries of more than 30 patients. Carotid artery stenting is often performed on carotid arteries that have developed blockages as a result of plaque buildup on the artery walls. The Rubicon Filter is designed to help physicians prevent embolic events from occurring during carotid. Rubicon Medical said it plans to use the collected data to generate the necessary reports and file for regulatory approval for marketing clearance for the product in Europe.

Siemens Medical Solutions (Malvern, Pennsylvania) introduced its latest ultrasound product, the all-digital Sonoline G20, at the 52nd annual clinical meeting of the American College of Obstetricians and Gynecologists (ACOG; Washington) in Philadelphia, Pennsylvania. The company said the system combines "excellent image quality, workflow enhancements and ergonomics" to provide improved performance and value. Within the Sonoline product line, the G20 fits between Siemens' existing offering of the Adara and the G50. The system is meant for physician offices. Siemens also reported the release of the first clinical images acquired using a 64-slice computed tomography system, at Friedrich-Alexander University (Erlangen/Nuremberg, Germany). The Somatom Sensation 64 has the ability to visualize the smallest intracranial, pulmonary, mesenteric and peripheral vessels in less than 10 seconds. The Somatom Sensation 64, cleared for the U.S. market in April, provides 64-slice sub-millimeter imaging per rotation for sub-millimeter volume coverage, and fast gantry rotation time at 0.37 seconds. Acquisition of 64 slices per rotation is possible through the new Straton X-ray tube's "Double z-Sampling" technology and new detector technology.

St. Jude Medical (St. Paul, Minnesota) reported FDA approval of the Riata i lead family, which the company called "the world's thinnest integrated bipolar implantable cardioverter defibrillator leads." The isodiametric body diameter of Riata i leads measures 2.2 mm or 2.5 mm (depending on model), and fits an 8 Fr introducer. The new Riata i lead family allows physicians even more versatility when managing patients with high defibrillation thresholds. The leads are multi-lumen silicone leads with St. Jude's Fast-Pass coating for improved lubricity.

TherMatrx (Northbrook, Illinois) has received FDA approval to market a shorter-length treatment catheter that will allow more patients to benefit from treatment with TherMatrx Dose Optimized Thermotherapy (DOT) for benign prostatic hyperplasia (BPH). The shorter-length Rx-200 catheter is designed to treat patients with shorter prostate lengths. TherMatrx DOT is an in-office treatment for men suffering from BPH and is designed to deliver maximum efficacy and patient comfort while minimizing side effects and risk.

Thoratec (Pleasanton, California) reported the expansion of its Phase I feasibility trial for the HeartMate II left ventricular assist system (LVAS). The HeartMate II is a next-generation heart assist device designed to provide long-term cardiac support for patients with end-stage heart failure. The trial, which originally allowed enrollment of up to seven patients in four institutions, will enlist up to 15 patients at up to 10 centers in the U.S. The company said that at least four of the additional six centers to be added to the trial have already been identified, received all necessary internal approvals, and have been trained on the technology, allowing them to begin screening and treating patients immediately. Thoratec also reported that the FDA has approved HeartMate II patients in the clinical trial to be discharged to a home setting from the hospital, based on the positive outcomes of the trial to date.

Toshiba America Medical Systems (TAMS; Tustin, California) said a research study in the April issue of Investigative Radiology showed its SureCardio multi-segment reconstruction applications to be clinically superior to standard halfscan reconstruction of 16-slice coronary computed tomography angiography performed on its Aquilion 16 CFX CT system. Each test result revealed that multi-segment reconstruction offered significant measurable improvements over half-scan reconstruction in patients with normal heart rates and reduced the acquisition time per heartbeat. Researchers said the results were almost completely attributable to the higher image quality of multi-segment reconstruction, which produced images of the coronary arteries free of motion artifacts. SureCardio applications enable the Aquilion CFX products to produce precise MPR images, volume curves and polar maps, as well as wall motion analysis and functional parameter calculations.

Vertebron (Stratford, Connecticut) reported the first surgical cases using its recently FDA-approved Vertebron PSS Pedicle Screw System. The PSS system incorporates an initial threadless locking and final low torque locking design. The company said it also is planning to release complementary allograft systems within the next quarter. The first spinal surgery cases using the PSS system were completed at centers in Colorado, Missouri and Ohio.

Vision-Sciences (Natick, Massachusetts) received FDA clearance to market its new Flexible Cystoscope with Slide-On EndoSheath System in the U.S. The system presents a new concept that provides urologists with a flexible endoscope that revolutionizes practice efficiency and patient protection. Each new Cystoscope System is comprised of a re-useable flexible cystoscope and a sterile, single-use Slide-On EndoSheath that contains a working channel for suction or irrigation, the passage of working instruments used for stent deployment and removal, and to take biopsies. Use of the EndoSheath System eliminates the necessity to perform high-level disinfection of the cystoscope after each procedure, a requirement that can consume up to 45 minutes of valuable office procedure time, the company said. Separately, Vision-Sciences reported FDA clearance to market the ENT-2000VE, a flexible video-enabled endoscope (VEE) for the ear, nose-and throat (ENT) market. The VEE architecture is a hybrid between a video and fiberoptic endoscopes. The insertion tube contains a glass fiber bundle, but the optical eyepiece is eliminated, being replaced with a CCD camera integrated in the VEE handle.

WorldHeart (Ottawa, Ontario) received conditional approval from the FDA last month to proceed with full enrollment of recipients in the RELIANT (Randomized Evaluation of the Novacor LVAS In A Non-Transplant Population) trial. The RELIANT trial, first unveiled by the company last November, will randomize patients to receive either a Novacor LVAS or a Thoratec (Pleasanton, California) HeartMate XVE LVAS on a 2:1 ratio. The Novacor system is an implanted, electromagnetically driven pump that provides circulatory support by taking over part or all of the workload of the left ventricle. The FDA's conditional approval for the trial permits immediate enrollment of up to 390 patients at up to 40 centers in the U.S. The primary enrollment will be 300 patients, with about 90 more patients expected to be enrolled during the follow-up period.

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