Continuing its bid to become the "duct tape" of surgical procedures, MacroPore Biosurgery (San Diego, California) last month received FDA clearance for CardioWrap, a bioresorbable film indicated for the repair of the pericardium, the protective sac that surrounds the heart. CardioWrap is the first bioresorbable pericardial repair product cleared by the FDA, marking another industry first for MacroPore's thin-film platform technology, the company said.

The clearance for CardioWrap further expands the approved applications for the SurgiWrap technology in the U.S., which was granted a U.S. patent in March.The thin-film technology products are currently cleared in the U.S. for soft tissue support, specific pelvic applications, ophthalmology indications and adhesion control for specific ear, nose and throat procedures. In addition, some of its products designed for use in spine, neurosurgical and musculoskeletal surgeries are distributed by Medtronic (Minneapolis, Minnesota).

Matthew Scott, vice president of sales for MacroPore, compared the bioresorbable film to the plastic wrap used to keep food fresh. "It's essentially the same feel as Cling Wrap, but it's designed as a protective band aid or a protective covering, he told The BBI Newsletter. "In this case, a protective covering for the healing heart." The film is composed of a polymer made of lactic acid that easily resorbs into the body. The body recognizes the lactic acid in the polymer as a natural component and does not reject it. Ultimately, it will be gone from the body in a year and like naturally occurring lactic acid in the body, it is disposed of via a chemical process known as the Krebs cycle.

Aside from general cardiac surgery, Scott said that the film could be used in left ventricular assist device procedures and a surgery called a Norwood procedure, in which a child's defective heart is repaired. It can be used, he said, in "any procedure where the surgeon is removing the pericardium and he wants a pericardium replacement that's the primary use." The CardioWrap will not be the company's primary moneymaker; most of the procedures for the SurgiWrap brand are in the areas of general surgery and obstetrics/gynecology. "It'll be a smaller component of our business [but] ... it's really important from a patient need standpoint," Scott said. However, he noted that the CardioWrap approval is a "building-block component to specifically limiting the soft tissue attachment to control scarring, so that's kind of the ultimate goal for us. We're not there yet, but we have to have these building blocks in place for FDA to give us that opportunity."

The company is constantly looking at potential new uses for the film that only enhance the duct tape analogy. Scott said that he was about to sit in on an off-label use of the product in the treatment of a gastric bypass. He said the surgeon was going to place SurgiWrap at the site of the laparoscopic surgery in order to prevent scarring that could potentially cause a hernia. He also said that in another instance, a surgeon treating carpal tunnel wanted to wrap tendons in a patient's wrist to prevent scar tissue that could prevent the flexion and extension of the wrist, another off-label use. "Those are the surgeries that I go to because those are the markets that we're going to be in."

Elsewhere in the product pipeline:

Alveolus (Charlotte, North Carolina) received regulatory approval in the European Union for a new implantable device to be used in non-vascular interventional pulmonary stenting. Alveolus attained FDA approval in the U.S. earlier this year and has already begun domestic commercialization.

Axeda Systems (Mansfield, Massachusetts) reported that Elekta AB (Stockholm, Sweden) has licensed the Axeda DRM system to further improve Elekta's service and remote diagnostics capabilities for its digital linear accelerators. The Axeda DRM system is a distributed enterprise software solution that allows instrument manufacturers to leverage the Internet to establish continuous connections to instruments deployed remotely at hospitals and treatment centers. Axeda DRM enables service organizations to proactively monitor, diagnose and repair instrument problems remotely, or schedule maintenance appointments to alleviate developing problems before instruments actually fail. The Axeda DRM System also can enable new, high-value managed-service offerings such as automated consumable replenishment, system upgrades and pay-for-use billing.

BioSyntech (Laval, Quebec) reported that under Health Canada's Special Access Program for Medical Devices, Hockey Hall of Famer Serge Savard was treated with its BST-CarGel in an effort to regenerate cartilage in his knee. The program allows physicians to obtain and use medical devices that are not marketed in Canada, under compassionate grounds. Dr. Nicolas Duval, an orthopedic surgeon in Montreal, filed the request with Health Canada and performed the surgery in late August, which required only a small incision to the knee. Duval stated: "I have no treatment alternatives other than total knee replacement (TKR), for cases like Mr. Savard. BST-CarGel offers Mr. Savard the best and only chance to regenerate his damaged cartilage, and thus delay or eliminate TKR and its associated patient impact." Savard is board chairman of BioSyntech, whose current efforts revolve around getting BST-CarGel into clinics and onto the market. The product is currently under review for CE marking, and BioSyntech planned to meet with Health Canada and the FDA in September to discuss the potential of initiating human clinical trials.

Bruker Daltonics (Billerica, Massachusetts) introduced the autoflex TOF/TOF system, a compact high-performance MALDI-TOF/TOF mass spectrometer. The system enables fast, automated protein identification by MALDI-TOF peptide mass fingerprinting, immediately followed by more detailed protein structural characterization using MALDI-TOF/TOF tandem mass spectrometry. The autoflex TOF/TOF benefits from Bruker's MALDI sample targets, which use the industry-standard microtitre plate format and thus are compatible with many standard microbiology or clinical diagnostics sample preparation robots.

Cardima (Fremont, California) has initiated its marketing campaign for the newest addition to its Revelation family of linear ablation catheters, the Revelation Helix STX 2.5, or "large loop" version of the Revelation Helix in Europe. The catheter's 16 short (3 mm in length) fine wire electrodes allow for greater radial hoop pressure, better tissue contact and an enhanced current density effect than conventional catheter designs, the company said. The first commercial use of the STX 2.5 for the treatment of atrial fibrillation (AF) originating in the pulmonary veins took place in August at Justus-Liebig-Universitat (Giessen, Germany). Cardima also said that doctors at Lenox Hill Hospital (New York) reported success in the first case application of its Surgical Ablation System to treat AF. The system, which ablates cardiac tissue during heart surgery using radio frequency energy, was used in a procedure to treat a patient with a history of chronic AF.

CAS Medical Systems (Branford, Connecticut) said has begun to incorporate OxiMax pulse oximetry technology developed by Nellcor (Pleasanton, California) into its Model 511 Cardio-Respiratory Monitor, the only apnea monitor with integral pulse oximetry cleared by FDA for use with neonates, pediatric patients and adults. The OxiMax technology features advanced digital signal processing, which CAS said enables it to read through the most challenging pulse oximetry conditions. The 511 Cardio-Respiratory Monitor features heart rate, respiration and oxygen saturation monitoring in one device. Other features include battery operation for continuous monitoring and data selection when AC power is unavailable, expandable memory through a removable PC memory card, a variety of data storage, airflow interface and a central alert display interface for hospital use to enhance alarm recognition.

Centerpulse Orthopedics (Austin, Texas) reported a new component of its CARE minimally invasive surgery (MIS) program with the launch of www.caremis.com. For patients, the web site explains the potential advantages of minimally invasive surgery, covers MIS technologies for both hip and knee replacement and includes downloadable patient education booklets. For surgeons, the site includes detailed product information, clinical results, downloadable surgical techniques and an up-to-the-minute calendar of MIS educational courses. The CARE (comprehensive accelerated recovery experience) MIS program was founded on the philosophy that education and support are essential for surgeons to gain confidence implementing minimally invasive surgical techniques and technology.

Charles River Laboratories International (Wilmington, Massachusetts) reported the launch of the Endosafe-PTS. The PTS is a portable test system based on the Limulus Amebocyte Lysate (LAL) assay. The LAL test is used to detect microbial contaminants in injectable drugs and medical devices. The PTS uses disposable cartridges loaded with FDA-licensed LAL reagents with a hand-held spectrophotometer. Testing can be performed at the point of sample collection and quantitative LAL results are available in approximately 15 minutes, about 45 minutes less than the time required for the conventional chromogenic LAL test.

CryoCath Technologies (Montreal, Quebec) said it will voluntarily replace certain production lots of catheters related to an earlier design that is no longer marketed in the company's 7F catheter line Freezor, Freezor Xtra and Arctic Circler. SurgiFrost and Freezor MAX are not affected by this field action. The new design that incorporates a minor change for Freezor, Freezor Xtra and Arctic Circler has been marketed for several months and remains available to CryoCath's customers. The company said it is taking this preemptive measure after confirming the circumstances of a single recent adverse event, which occurred in a patient who fully recovered in a few minutes and was released from the hospital on schedule. No other patient complaints or adverse events related to this type of product failure have ever occurred, CryoCath said. The revised product design for the 7F catheter products, which has been manufactured and distributed since earlier this year, was fully validated by laboratory testing to correct the observed deficiency.

Cyberonics (Houston, Texas) received FDA approval to market the VNS Therapy Model 102R Generator in the U.S. for the treatment of pharmacoresistant epilepsy. The Model 102R Generator is a dual-connector version of the Model 102 Generator for use as a replacement for Model 100 and 101 generators with dual connector Model 300 leads that have reached the end of service. The Model 102R is slimmer, lighter and easier to implant than its dual connector predecessor, the Model 101 Generator, the company said.

Digene (Gaithersburg, Maryland) said that Laboratory Corp. of America Holdings (LabCorp; Burlington, North Carolina) is now offering clients Digene's DNAwithPap Test for cervical cancer screening and cervical disease identification. The DNAwithPap Test is based on the hc2 High-Risk HPV DNA Test and is FDA-approved for women age 30 and older to adjunctively screen with a Pap test to assess the presence or absence of high-risk HPV types as a guide for patient management.

Fischer Imaging (Denver, Colorado) said the FDA has authorized the American College of Radiology (ACR; Reston, Virginia) to act as the official accreditation agency for its SenoScan digital mammography breast scanning system. Since the FDA's premarket approval of SenoScan in September 2001, all SenoScan customers have had to file for accreditation directly with the FDA. The company said registration through the ACR will enable its customers to enjoy a more streamlined and simplified accreditation process, one that is more consistent with the existing requirements for film screen mammography units. ACR accreditation also eliminates the federal requirement that a facility with a SenoScan digital mammography system also have available a separate film-screen mammography unit, the company said.

Implant Sciences (Wakefield, Massachusetts) has expanded its prostate seed line and is now accepting orders for an assembly of needles preloaded in the Readi-Load system using free seeds and spacers and Readi-Strand, a strand of the company's radioactive I-Plant seeds connected and precisely spaced within resorbable material for the treatment of prostate cancer. This stranded implant maintains the I-Plant seed positions within the prostate gland for at least two months after the procedure and ensures that the prescription dose is achieved at every point within the prostate gland. Both of the new technologies were developed and are owned by World Wide Medical Technologies.

Intuitive Surgical (Mountain View, California) said that its da Vinci robot surgical system was used in the first pediatric robotic surgery. David Partrick, MD, director of surgical endoscopy for infants and children at The Children's Hospital (Denver, Colorado) used the da Vinci to perform gallbladder surgery on a 16-year-old patient. With the new instrumentation, the surgical incisions are as small as 5 mm long. By using the mechanical arms and eyes of the da Vinci robot, surgeons can perform minimally invasive operations remotely by using controls on a computer console operations that result in smaller incisions and give patients faster recovery times.

Medtronic Vascular (Santa Rosa, California) reported FDA clearance and U.S. availability of the Aurora Self-Expanding Biliary Stent System, designed to maintain bile flow in ducts restricted or blocked by malignant tumors. The Aurora system includes six radiopaque, MRI-compatible gold stent markers that provide physicians a clear view of stent positioning and placement. The system's one-step, single-handed delivery system allows physicians to easily maneuver, track and deploy the stent, potentially minimizing procedure time, compared to prior versions of Medtronic's self-expanding stent delivery systems.

Mentor (Santa Barbara, California) said that its new surgical implant for treatment of stress incontinence in women has been approved by the FDA. The new product, the ObTape transobturator sling, will be launched in the U.S. market this month. The procedure is simpler and faster, with less risk of complications, than alternative procedures, the company said. In the last two years more than 11,000 women in Europe have been successfully treated for stress incontinence with Mentor's transobturator sling.

Nellcor (Pleasanton, California), a unit of Tyco Healthcare, said that an article published in the June/July issue of Neonatal Intensive Care highlights its SatSeconds Alarm Management technology as a solution for reducing pulse oximetry nuisance alarms in neonatal intensive care units. SatSeconds is a clinician-programmable function featured in the Nellcor OxiMax Pulse Oximetry System that helps reduce alarms caused by mild and brief oxygen desaturation events. The article examines how the technology gives caregivers a more effective way to manage clinically insignificant alarms without sacrificing patient safety. The SatSeconds feature has been shown to decrease the number of false positive alarms by up to 70%. Available in Nellcor's OxiMax N-595 Pulse Oximeter, SatSeconds analyzes desaturation events by multiplying their duration by the number of percentage points the patient exceeds the alarm limit.

Novare Surgical Systems (Cupertino, California) reported the issuance of U.S. patent No. 6,544,274 covering the company's Cygnet line of dual-action surgical clamps for minimally invasive coronary artery bypass graft surgery, valve replacement surgery and aortic aneurysm repair. Designed to be either rigid or flexible, providing greater access to the surgical field, the Cygnet product line represents a key base-technology for extending Novare's products into new markets, including the treatment of atrial fibrillation (AF), the most common type of abnormal heart rhythm. Novare also reported it has entered into a multiple-year supply agreement with Boston Scientific (Natick, Massachusetts) under which that company will purchase specially modified models of Novare's Intrack line of atraumatic surgical clamps and market them as part of its new Cobra Bipolar System used treat AF with radiofrequency waves.

Ophtec USA (Boca Raton, Florida) and Advanced Medical Optics (AMO; Santa Ana, California) said that Ophtec's premarket approval (PMA) application for the Artisan/Verisyse phakic intraocular lens has been accepted by the FDA and has been assigned expedited review status. The current PMA application is for the correction of near-sightedness, or myopia, in phakic eyes in the range of -5.0 diopters to -20.0 diopters. Ophtec will continue to market the product under the trade name Artisan, while AMO, with global distribution rights, will market the product under the name Verisyse, which it has done in Europe since 2002. AMO is the exclusive distributor for the product in North America and Japan.

RITA Medical Systems (Mountain View, California) introduced the StarBurst Semi-Flex, a flexible radiofrequency ablation device targeting the interventional radiology market. The product is designed for ease of use during ablation procedures using imaging modalities including magnetic resonance imaging, ultrasound and computed tomography. Semi-Flex is CE marked, and is FDA-cleared for use in the treatment of tumors of the liver, bone and soft tissue. The product features a longer (25 cm) and more flexible needle to enable ablation of deeper, more centralized cancerous lesions and does not require an introducer even when penetrating dense tumors. Semi-Flex enables radiologists to easily position the device in imaging systems while performing image-guided percutaneous procedures.

Siemens Medical Solutions (Malvern, Pennsylvania) introduced bonSAI, a fluorescence optical imaging technology that enables in vivo imaging of molecular processes, at the annual meeting of the Society for Molecular Imaging (Stanford, California) in San Francisco, California. bonSAI was developed to support the needs of pharmaceutical and biotechnology research organizations by aiding in target identification and early prioritization of candidate drug compounds, thus speeding up research and development efforts and decreasing time to market.

Spectranetics (Colorado Springs, Colorado) said the FDA approved a labeling change for its excimer laser coronary atherectomy catheters that allows individualization of use for treatment of patients with acute myocardial infarction, acute thrombosis, or ejection fraction less than 30%. Under the new labeling, patients with these clinical conditions can be treated with the laser after consideration by their physician.

SpineCore (Summit, New Jersey) has initiated a nationwide clinical trial for its FlexiCore Intervertebral Disc. The disc is intended to replace a degenerated disc in the lumbar spine and permit motion of the treated segment, improve function and reduce back pain associated with degenerative disc disease. The company was granted an investigational device exemption by the FDA.

St. Jude Medical (St. Paul, Minnesota) reported the first patient enrollment in the ASSIST (Atrial Tachyarrhythmia Suppression Strategy in ICD Subjects Trial) clinical study. The purpose of the ASSIST study is to evaluate if atrial fibrillation (AF) suppression pacing in dual-chamber ICD patients will reduce atrial arrhythmia burden and the frequency of inappropriate VT/VF therapy in patients with a history of paroxysmal atrial fibrillation. The patient received a St. Jude Medical Epic+ DR implantable cardioverter defibrillator (ICD) with clinically proven AF Suppression technology. The ASSIST trial is a randomized study being conducted at 40 centers across the country. The trial is estimated to last two years to achieve the study population.

SYN X Pharma (Toronto, Ontario) said that the company received the CE mark to sell its Nexus Dx point-of-care cardiac product line in Europe. SYN X currently has Health Canada approval and is selling and distributing the tests through its alliance with VWR International (West Chester, Pennsylvania).

Vascular Solutions (Minneapolis, Minnesota) said that it has received CE mark approval for its Pronto extraction catheter. The Pronto consists of an extraction catheter with a proprietary atraumatic distal tip and large extraction lumen that can be delivered into arteries to remove soft thrombus. A user-friendly syringe extraction system allows for a single operator deployment with total preparation and deployment time of less than two minutes.

Vital Images (Minneapolis, Minnesota) has signed an agreement with Mirada Solutions Ltd. (Oxford, UK) to integrate Mirada's positron emission tomography (PET) and image fusion software into Vital Images' Vitrea software. Vitrea 2 features real-time navigation of 3-D volume data, permitting the user to create 2-D and 3-D views of human anatomy and to interactively navigate within these images to better visualize and understand internal structures and disease conditions. Mirada's technology can fuse images from the same or different imaging modalities from datasets acquired at different times; or from datasets generated on equipment from different manufacturers. Vital Images plans to demonstrate the integrated technology at the annual meeting of the Radiological Society of North America (Oak Brook, Illinois) in early December, followed by a commercial launch in 2004.

Zoll Medical (Chelmsford, Massachusetts) and Revivant (Sunnyvale, California) reported an agreement aimed at the commercialization of Revivant's AutoPulse cardiopulmonary resuscitation (CPR) product. The AutoPulse, a new FDA-approved portable device that automates chest compressions, has been shown to greatly increase blood flow to the brain and heart compared to manual CPR. The AutoPulse is currently sold in the U.S. and is being used clinically in a number of sites. The AutoPulse holds the promise of being able to resuscitate patients who have been in arrest for an extended period of time, the companies said.