Help is on the way for the youngest of diabetic patients. Cygnus (Redwood City, California) received from the FDA a supplemental premarket approval for use of the GlucoWatch G2 Biographer in children and adolescents between 7 and 17. The G2, which will be available by the end of this month, is the second-generation model of the GlucoWatch Biographer, a monitoring system that provides glucose readings continuously, automatically and non-invasively. Earlier this year, Cygnus received FDA approval to use the device with adults.
"We truly believe the use of this product can help improve the lives of the growing population of children with diabetes," CEO John Hodgman said in a conference call. "We hope and believe that some day in the future there will be a cure for diabetes. Until that day comes, the only solution to really improving lifestyles for people with diabetes is frequent glucose monitoring. And the only solution today is the GlucoWatch Biographer."
The two-part device consists of the Biographer, a watch-like device that is worn on a wrist, and the AutoSensor, a disposable component attached to the back of the device that allows for glucose monitoring for up to 13 hours. Its follow-on approval was based in part on data culled from a 66-patient study showing that younger patients displayed a significant and sustained improvement in glucose control.
A growing market demands such a device to serve a younger population. Of the estimated 17 million U.S. diabetics, about 150,000 are less than 20 years old. Every year, nearly 13,000 new cases are diagnosed in children. "The risk of developing diabetes is higher than virtually all other severe chronic childhood diseases," Hodgman said. "We believe that our GlucoWatch G2 Biographer can greatly reduce the health risks for patients with diabetes."
The G2 Biographer differs from conventional blood glucose monitoring devices in a number of areas. It measures and displays glucose levels automatically and continuously for up to every 10 minutes. "The frequency of the automatic and non-invasive reading gives patients and their caregivers more complete information about glucose levels, allowing them to make better informed decisions regarding diet, medication and physical activities," Hodgman said.
Its non-invasive method collects glucose through the skin, not from blood. It also creates an electronic diary, storing up to 8,500 glucose values that can be reviewed to help detect trends and patterns in glucose levels.
The G2 Biographer also features a number of improved functions over the first-generation model. Its warm-up time — an initial wearing period before readings are available — was reduced from three hours to two hours. Also, its audible alert can provide predictive notification before a pre-set low glucose value is actually encountered. For example, the device helps detect hypoglycemia before a severe episode happens such as a seizure or a critically low glucose level. Readings can be obtained for as long as 13 hours, 60 minutes longer than before.
The G2 is intended for use by children, adolescents and adults, though it is not intended to replace the common fingerstick testing method. It is indicated to detect and assess episodes of hyperglycemia and hypoglycemia, allowing both acute and long-term therapy adjustments.
The product is being marketed in collaboration with Sankyo Pharma (Tokyo), a wholly owned subsidiary of Sankyo. The firms signed an expanded agreement in July, with Sankyo responsible for promoting, marketing and distributing the product through a 100-person specialty sales force. Sankyo also will provide broad market coverage through its 450 primary care sales representatives. The initial agreement was reached last November. Sankyo also may deploy 20 managed care account managers to obtain insurance reimbursement for the GlucoWatch Biographer and 20 medical managers who would communicate key scientific data to medical professionals.
CFO/COO Craig Carlson said Cygnus would be responsible for R&D, clinical, regulatory and manufacturing costs.
Elsewhere in the product pipeline:
Abbott Laboratories (Abbott Park, Illinois) said it anticipates that more breast cancer patients will benefit from use of its Vysis PathVysion fluorescence in situ hybridization (FISH) test as a result of the FDA's approval to include information about it in the labeling for Herceptin, a monoclonal antibody treatment for women with metastatic breast cancer. Abbott said PathVysion represents one of the first examples of genomic disease management detecting HER-2/neu gene status as the means to accurately identify which women are potential candidates for Herceptin. The company added that the presence of multiple copies of the HER-2 gene plays a pivotal role in the rapid growth of tumor cells in 25% to 30% of breast cancer patients. Women with HER-2 positive breast cancer also experience resistance to therapy and decreased survival. Determination of HER-2 gene status is a critical tool for selecting therapeutic options, because certain breast cancer treatments are more appropriate when multiple copies of the gene are found. Herceptin, marketed by Genentech (South San Francisco, California), is a targeted monoclonal antibody treatment for women with HER-2 positive metastatic breast cancer, an especially aggressive form of the disease. Vysis (Downers Grove, Illinois), a subsidiary of Abbott Labs, focuses on genomic disease management.
Bionomics (Adelaide, Australia) said it created the world's first animal model of inherited human epilepsy. Bionomics has developed a mouse model that exhibits epileptic seizures like those found in humans. The company said the new mouse model contains a genetic mutation representative of human epilepsy and we will now be able to assess more closely the neurological and physiological mechanisms causing epilepsy. Bionomics combines its genomics-based research focus on the discovery of genes associated with serious medical conditions with validation and development efforts leading to new drugs, gene therapies and diagnostic applications. Its research and development activities are directed toward breast cancer, epilepsy and angiogenesis.
Boston Scientific (Natick, Massachusetts) received FDA premarket approval for its Express2 coronary stent system. The company said it plans to launch the product immediately. The Express2 coronary stent system, launched in Europe in May and in other international markets in June, is a laser-cut, balloon-expandable stent that features a design concept called Tandem Architecture. Tandem Architecture integrates short, thin Micro elements designed for flexibility and conformability, with long, wide Macro elements designed to enhance radiopacity. Combined, the elements are designed to create a structure that offers uniform vessel coverage, radial strength and clean acute angiographic results. The Express2 coronary stent system, an Express stent combined with advanced Maverick balloon catheter technology, features a laser-bonded, flexible tip with a long, low profile designed for easier tracking. Its Bioslide hydrophilic coating is designed to reduce friction, while its Crimp 360 technology secures the stent to the balloon.
Carmeda (San Antonio, Texas) reported publication in the June issue of Comparative Medicine of a paper describing benefits of the company's BioActive Surface applied to central venous catheters in a controlled study in rats comparing coated to uncoated polyurethane catheters. At the 30-day endpoint of the blinded study, nine of nine Carmeda-coated catheters were open for infusion and aspiration while two of eight uncoated catheters were similarly patent. Also, though not statistically significant, three positive blood cultures were observed in the uncoated group while none were observed in the Carmeda-coated group. The results are consistent with clinical findings in shorter-term human studies (less than 10 days). The paper also reported on pathologic findings comprising inflammatory activity that was more extensive and generally more involved in the specimens from rats with uncoated catheters.
CellFactors plc (Cambridge, UK) said its human cell-derived bone-regeneration product, Skeletex, successfully demonstrated in an in vivo preclinical model its ability to induce the spontaneous formation of new bone. CellFactors said several orthopedic companies are evaluating the product to potentially license the material for orthopedic uses such as spinal fusion and prosthetics. The company said it intends to develop Skeletex for dental applications, such as implants and periodontal disease. It said it expects to enter Skeletex into clinical trials in this area next year. Skeletex is a stable, cell-free, orthobiological product containing about 70 human cell factors extracted from an immortalized, partially differentiated cell line grown in laboratory culture. The original cells, collected from human fetal tissue, are termed partially differentiated because they are at the earliest stage at which they are committed to becoming a specific cell type with a specific function in the body.
Chemicon International (Temecula, California), a provider of immunological and molecular biology reagents and tests, released the ATA100 Advanced Tissue Arrayer. Designed and manufactured in collaboration with Advanced EDM Automation (Poway, California), the Advanced Tissue Arrayer offers high-quality, low-cost arrays to meet the needs of the proteomics market. Chemicon said the instrument is complementary to its immunological and molecular biology technology platforms.
Equidyne (San Diego, California) received 510(k) clearance from the FDA for over-the-counter (OTC) sale of its needle-free Injex 30 system for insulin administration. The Injex needle-free injector is a compact device that delivers a virtually painless injection through the skin in a fraction of a second, eliminating needle stick and disposal problems. The company said OTC approval further affirms the product's safety and ease of use. OTC marketing of the Injex 30 system will require specific product and packaging labeling changes to differentiate the OTC version from the currently marketed Injex 30 system requiring a prescription. Equidyne said it does not plan to begin over-the-counter sales before developing a partnership or licensing arrangement to facilitate OTC sales.
Geron (Menlo Park, California) published in last month's issue of Circulation Research research describing the differentiation of cardiomyocytes from human embryonic stem cells. The studies show that functional, contractile cardiomyocytes can be differentiated from human embryonic stem cells and have potential for clinical use in treating diseases such as acute myocardial infarction and heart failure. The differentiated cardiomyocytes contracted for over 70 days in vitro and expressed molecular markers characteristic of human cardiomyocytes as well as proteins such as cardiac troponin I and N-cadherin. Further, pharmacological agents modulated the contractile rate of the hESC-derived cardiomyocytes in the same manner as observed with cardiomyocytes isolated from primary heart tissue.
Given Imaging (Yokneam, Israel) reported publication in last month's issue of Gastrointestinal Endoscopy study results that concluded that its M2A capsule endoscope identified small intestinal bleeding sites beyond the range of push enteroscopy. The study also concluded that capsule endoscopy provides excellent visualization of the small intestine, and is well tolerated and safe. The data formed the basis of last year's FDA approval of the M2A capsule. Results showed a bleeding site was found in 11 of 20 patients during the capsule endoscopy procedure. No additional intestinal diagnoses were made by enteroscopy. The yield of push enteroscopy in the evaluation of obscure bleeding was 30% vs. 55% for capsule endoscopy.
An FDA advisory panel last month recommended market clearance of the Excluder Bifurcated Endoprosthesis, an implantable device developed by W.L. Gore & Associates (Sunnyvale, California) for use in endovascular repair of an abdominal aortic aneurysm (AAA). Gore seeks to market Excluder to treat infrarenal AAAs as an alternative to surgery. That treatment alternative offers significant opportunity, the company said, since AAA is currently the 13th leading cause of death in the U.S. and with 2000,000 currently diagnosed as at risk for aneurysm rupture. The Excluder is implanted in the abdominal aorta in two sections: the trunk and the contralateral leg. The trunk is placed just below the renal arteries and includes one full leg, which extends into one iliac artery. Meanwhile, the contralateral leg component is placed in the other iliac artery to form a full endovascular graft. Together these two pieces form a bifurcated endovascular graft, according to Gore. The device would remain inside the aorta permanently through the use of metal prongs or anchors, as well as via radial force — meaning a tight fit — against the wall of the aorta. About 4,400 Excluders have been implanted in patients outside the U.S. In pivotal trials, 93% of patients implanted with the device experienced either tumor shrinkage or stabilization over a two-year period, said Jon Matsumura, assistant professor of surgery, division of vascular surgery at Northwestern University Medical School (Evanston, Illinois), speaking on behalf of the company. Compared to conventional open surgery, the clinical benefits of the Excluder Bifurcated Endoprosthesis are a lower rate of major complications, reduced blood loss and blood replacement volume, reduced need for an ICU stay, shorter hospitalization and faster return to normal activities, according to the company. The risks were associated with the procedure or the device, to include endoleaks or an increase in aneurysm size.
Guidant (Indianapolis, Indiana) completed enrollment in a company-supported optical coherence tomography study that examined images of lesions in patients with coronary artery disease. Guidant said a newly established body of evidence shows that as many as 85% of heart attacks are triggered by complex vulnerable lesions — vulnerable plaque — that suddenly cause blood to clot and occlude the artery. According to the company, research suggests that local therapies may be effective in treating vulnerable plaque as a component of optimal patient management. Optical coherence tomography is a new coronary imaging technology that the company said provides resolution ten times greater than intravascular ultrasound. Investigators in the Guidant-supported study used this new technology to gather highly detailed information about the unique characteristics of complex lesions that may lead to a heart attack. The study enrolled 63 patients.
Heartlab (Westerly, Rhode Island) said it completed an internationalization project for software globalization and multi-lingual information processing. Heartlab internationalized its Encompass Review Station software in preparation for its global distribution, with Japan as the first international market. By Unicode-enabling the product, Heartlab will be able to support Japanese and add other languages in the future. In addition, support was added for the international features of the DICOM communications protocol, an industry standard for the transmission of medical images and their associated information. The review station is part of Heartlab's Encompass Cardiac Network, which connects to all major cardiac X-ray and ultrasound systems using DICOM. The system creates a central repository of digital images from multiple modalities together with the associated physician findings reports. Using the network- connected review stations, clinicians can access several thousand diagnostic cardiac catheterization or echocardiography cases stored on the Encompass Enterprise Server, and access cases stored on the Encompass DVD Image Archive in about 30 seconds. The DVD Archive has scaleable capacity to store from 5,000 to more than 100,000 cases.
IMI International Medical Innovations (Toronto, Ontario) received CE mark approval for its skin cholesterol test, Cholesterol 1,2,3, a non-invasive cholesterol test system. It is cleared for use as part of risk assessment for coronary artery disease. Cholesterol 1,2,3 is a three-minute test that measures cholesterol in the skin, on the palm of the hand. By measuring cholesterol on the surface of the skin, IMI said Cholesterol 1,2,3 has been shown in clinical trials to provide new information about coronary artery disease risk that is independent of traditional risk factors such as blood cholesterol. Studies have shown a relationship between skin cholesterol and history of heart attacks, and have demonstrated the incremental value of using Cholesterol 1,2,3 in addition to traditional risk factors in assessing a risk of coronary artery disease.
Innercool (San Diego, California) has launched a new clinical trial for use of its Celsius Control system in the treatment of acute myocardial infarction. The Celsius Control System involves threading an endovascular catheter, via the femoral vein, to the inferior vena cava. The catheter contains circulating saline solution that is heated or cooled by a nearby console, thereby altering, in a rapid, targeted manner, the patient's core body temperature. When used in a hypothermia strategy — that is, mild cooling — the effect is, according to Innercool president and CEO John Dobak, MD, "multifactorial." He says that hypothermia serves to slow metabolic demands, reducing the stress on cells and thus retarding the damaging effect on tissues deprived of oxygen. The company also has submitted data from its Temperature Control During Aneurysm Surgery (TCAS) trial, designed to measure the Celsius Control System's ability to maintain a target temperature during the procedure and then return the core body temperature to normal (nomothermia). That data has been submitted to the FDA and Dobak says the company projects receiving a clearance "relatively soon." That clearance would be the first for the company in the U.S., Dobak noted, with product launch coming soon after, targeting the neurosurgical community. While that application is for a 510(k) clearance, Innercool must travel the premarket approval route for use of the Celsius system in the treatment of heart attack, that requirement based on a narrower, more critical application of the system, according to Dobak.
Ischemia Technologies (Denver, Colorado) said Canadian regulatory authorities granted marketing approval for its Albumin Cobalt Binding test, used to detect acute cardiac conditions in patients with chest pain. The test is available in Europe, with U.S. regulatory submission in process. It is used to diagnose acute coronary syndromes, which include unstable angina and acute myocardial infarction, in patients presenting to the emergency department with chest pain. Clinical studies have shown the test detects more than 90% of patients with ACS based on test results of their first blood draw when it was used in conjunction with current standards of care, ECG and the cardiac marker troponin. Currently, many patients fall into a gray zone in which cardiac chest pain cannot be quickly ruled in or ruled out. If identified quickly, patients with cardiac chest pain can be treated with drugs or other procedures that can minimize damage to the heart muscle.
Isolagen (Houston, Texas) received U.S. patent No. 6,432,710 titled "Compositions for regenerating tissue that has deteriorated and methods for using such compositions." The company said this invention could represent a "significant breakthrough" in the treatment of periodontal defects, adding that its initial focus will treat and restore gingival tissue in the interdental regions using autologous oral mucosal fibroblasts and it will explore areas of gum recession and recession after root planning or periodontal surgery. The dental patient's autologous cells are obtained via a 1 mm biopsy taken from the oral cavity and propagated to a new population of over 50 million cells. The cells are then delivered to the patient's area of treatment, eliminating the need for donor skin taken from the palate, or use of foreign substances to cover the recession.
Magna-Lab (Lynnfield, Massachusetts) received U.S. patent No. 6,437,569 with 33 claims for its Illuminator Probe, a non-invasive, expandable magnetic resonance imaging (MRI) receiving coil to advance the definitive diagnosis of coronary artery and other heart diseases. The probe is designed to operate in conjunction with existing MRI systems to generate diagnostic quality images of the major structures of the heart including the aortic arch, the descending aorta, and the coronary vessels of the heart. The device consists of an MRI micro receiver coil that is introduced in the patient's esophagus, using local anesthesia, and positioned directly behind the heart. The placement of the receiver closer to the heart increases the signal-to-noise ratio that provides the contrasting resolution needed to image the heart's tiny structures. The probe also can be used in conjunction with Magna-Lab's non-invasive Illuminator Surface Coil, which sits on top of a patient's chest while undergoing an MRI, to increase image clarity for certain diagnoses.
Med-Design (Ventura, California) submitted to the FDA a request for 510(k) clearance for its Safety Dental Injector, a one-handed, single-use, disposable syringe injector to deliver dental anesthetics. Sultan Chemists (Englewood, New Jersey), the product's exclusive distributor, will market the Safety Dental Injector directly to dentists and distribute the product through established dental product distributors. If the product is approved by the end of the year, Med-Design said shipments would begin in the first quarter of next year. Med-Design said preclinical reviews of the product show that dentists favor a one-handed, lightweight syringe injector. Sultan estimates its market to be in excess of 75 million units per year.
North American Scientific (Chatsworth, California) reported at the Congress of the European Association of Nuclear Medicine in Vienna, Austria, results of a Phase I study for safety, biodistribution and dosimetry of its Hynic-Annexin V product candidate, a kit for the preparation of Tc-99m labeled Annexin V, currently under study for in vivo imaging of cell death. Results demonstrated that the Hynic-Annexin V imaging agent was well tolerated in normal volunteers and that, after intravenous administration, the agent is cleared from the body by the kidneys. The study showed that Hynic-Annexin V is not cleared by the hepatobiliary system to any significant extent, and that, unlike previous formulations of Tc-99m labeled Annexin V, there was no bowel excretion of the agent. The absence of gastrointestinal clearance suggests that abdominal imaging should be relatively straightforward with Hynic-Annexin V.
Orqis Medical (Lake Forest, California) said its Cancion family of minimally invasive cardiac recovery systems received CE mark certification following successful European clinical trials. The Orqis system uses blood-pumping technology intended for percutaneous insertion under local anesthesia. The company said it expects to launch the Cancion systems next year. Orquis also has begun the application process to open an investigational device exemption trial in the U.S. Clinicians called the product an easy-to-implant, minimally invasive device that showed an improvement of the hemodynamic data as well as an improvement of kidney function. Data also showed the pump improved left ventricular filling pressure and reduced the level of brain and naturetic peptide in patients with renal dysfunction and heart failure maintained on inotropic support. The effect is sustained after pump removal and discontinuation of inotropic support.
Ortec International (New York) said OrCel will be featured in a case study in the peer-reviewed journal, Advances in Skin & Wound Care, representing the first report of clinical efficacy in a hard-to-heal venous leg ulcer using meshed OrCel. Prior experience with OrCel has been with non-meshed OrCel and, according to the authors, meshing OrCel expands its size and allows larger wound surfaces to be covered. As described in the article, due to the size of the wound and the lack of healing with multilayer compression dressing, the wound was treated with a single unit of meshed OrCel. The patient responded favorably with a decrease in wound size and rapid granulation tissue formation. Fifteen days after the initial OrCel application, OrCel was reapplied. At three months post-OrCel application, the wound had healed to one-fourth of its original size; it was completely healed by four months.
PharmaNetics (Raleigh, North Carolina) completed the target enrollment of 600 patients in its ELECT (EvaLuating Enoxaparin Clotting Times) study. The company said it expects to report results at the American Heart Association's (Dallas, Texas) November meeting in Chicago, Illinois. ELECT, conducted in patients undergoing percutaneous coronary intervention (PCI or angioplasty) procedures, evaluated the use of PharmaNetics' lead product, the Enox test, in conjunction with enoxaparin in facilitating treatment of acute coronary syndrome patients who may transition to PCI. The open-label, observational trial assessed the Rapidpoint Enox point-of-care device in patients receiving either subcutaneous or intravenous enoxaparin as the antithrombin therapy during PCI, with or without adjunctive platelet GP IIb/IIIa inhibitor therapy. The study's primary objective is to assess the predictive value of the Enox test to measure the whole blood anticoagulant effect of the low-molecular-weight heparin enoxaparin relative to ischemic and hemorrhagic outcomes associated with PCI. With this information, optimal therapeutic reference ranges for the performance of PCI with stent implantation and for post-PCI vascular sheath removal may be determined.
Somanetics (Troy, Michigan) received a patent, including 29 claims, related to its CorRestore System, used in cardiac repair and reconstruction, including surgical ventricular restoration (SVR). During SVR with CorRestore, a surgeon implants the CorRestore Patch to restore an enlarged, poorly functioning left ventricle to more normal size and function. SVR coupled with CorRestore corrects the cause of their congestive heart failure, as opposed to treating only the symptoms. The CorRestore System is an out-of-the-box repair device of a material and design specifically suited to SVR. The patented bovine pericardial patch has a ridged inner suture ring and a contoured outer rim, to provide a better seal on the edges of the patch to minimize leaking.
Soundtec (Oklahoma City, Oklahoma) received FDA approval for its Integrated Processor and Coil, a sound processor that is worn in the ear canal. The device will be available as a part of the Direct System for sufferers of mild to moderate sensorineural hearing loss. The Direct System consists of a tiny, rare earth magnet implanted in the middle ear, and a speech/sound processor. Implantation takes less than 30 minutes, and can be performed in an outpatient clinic under local anesthetic. The Direct System is capable of eliminating or reducing the major complaints typically associated with conventional acoustic hearing aids, such as feedback, occlusion effect, and distortion. Initial FDA approval of the Direct System using a behind-the-ear processor was granted last September.
Triage Medical (Irvine, California) received FDA clearance for an additional series of its Bone-Lok devices, allowing Triage to market all Bone-Lok products for the general management of fractures and reconstructive surgery throughout the body. Notably, the company now will be able to market products for the larger bone structures of the body, including hip fractures and reconstructive surgery. Bone-Lok devices use Triage's CLASP (Compression Locking Anchor with Secondary Purchase) technology for the fixation and surgical reconstruction of bone fractures. The company said initial testing has shown CLASP technology provides significantly greater compressive strength in fixating bone fractures than currently used devices. Triage added that the data also indicated that CLASP provides enhanced strength regardless of whether or not the bone fracture is compromised by osteoporosis. Triage said it expects to begin a limited product launch of its initial Bone-Lok devices in 4Q02. The company will continue a planned rollout in the U.S. and Europe, with worldwide distribution planned for completion by the end of next year.
Tissue Science Laboratories (TSL; Aldershot, UK) has launched Permacol surgical implant in the U.S. for the treatment of complex and recurrent hernias. Permacol collagen/elastin matrix already is approved in the U.S. and in most European countries for use across a number of surgical disciplines. Marketed in the U.S. by C.R. Bard (Murray Hill, New Jersey) for gynecological and urology applications, Permacol clinical trials have demonstrated effectiveness in primary inguinal hernia, according to TSL. The company said that interim clinical trial results comparing Permacol with polypropylene mesh had demonstrated its effectiveness without the risk of foreign body-type reactions associated with synthetic meshes. There also was a reported lower post-operative risk of hematomas.
The USS/DG division of United States Surgical (Norwalk, Connecticut), a unit of Tyco Healthcare, received FDA approval for its Indermil (n-Butyl-2-Cyanoacrylate) tissue adhesive to close topical skin incisions and lacerations. The product will be distributed by USS/DG. Indermil was developed and is manufactured by Henkel Loctite through its affiliate, Loctite Ltd. (Dublin, Ireland). The product is indicated for the closure of topical skin incisions and other trauma-induced lacerations in areas of low skin tension that are simple, thoroughly-cleansed, and have easily approximated skin edges. It may be used in conjunction with, but not in place of, deep dermal stitches. The company said that, unlike other closure options such as non-absorbable sutures or staples, which must be removed, Indermil, a clear tissue adhesive, gradually sheds from the wound in seven to 10 days when no longer required.
Venetec International (San Diego, California) released its StatLock Arterial Plus securement device, developed for safely and reliably anchoring intra-arterial lines. StatLock Arterial Plus replaces suture for catheter securement, a move Venetec said reduces the risk of potentially fatal bloodstream infections and accidental needlesticks. Three recently published studies have documented suture's involvement in such infections, and also demonstrated StatLock's ability to eliminate complications. StatLock also helps healthcare facilities meet federal and state mandates for the purchase of devices that protect healthcare workers against sharps injuries. Its releasable latch allows clinicians to adjust and reaffix the catheter to the anchor pad, minimizing the need to replace the catheter ahead of schedule. StatLock adhesive technology uses hydrocolloid and acrylic adhesives.
WorldHeart (Ottawa, Ontario) said that in response to a request by the Centers for Medicare & Medicaid Services (CMS), it forwarded data for consideration in the CMS review of CIM 65-15. CMS is considering expanding Medicare coverage to include destination-therapy use of ventricular assist devices (VADs) in end-stage heart failure patients who are not candidates for cardiac transplantation. If approved, expanded coverage would provide a life-saving option for many Medicare patients suffering from terminal heart failure, the company said. WorldHeart said interaction with CMS has been particularly frequent in the past few months as the agency is focusing significant attention on VADs, especially with its recent recommendation to create a new diagnosis-related group, Heart Assist System Implant. CMS is expected to render a destination-therapy coverage decision by Nov. 12. The company's submission is largely based on data and information included within its Aug. 14 premarket approval supplement (PMA-S) to the FDA to expand the use of its Novacor LVAS to include destination therapy, and is in support of destination therapy reimbursement by Medicare. An FDA filing decision regarding its PMA-S is expected soon, the company said. Novacor LVAS was FDA-approved in September 1998 for use as a bridge to transplantation, but no assist device is approved in the U.S. as destination therapy for heart failure patients.
X Technologies (Tustin, California) filed with the FDA the third and final module of its premarket approval application for its FX miniRAIL RX PCI Catheter. The module contains the results from a 263-patient, multicenter trial designed to investigate the safety and effectiveness of the angioplasty system. The company said the FX miniRAIL is a low-profile, 6 Fr-compatible system that integrates two flexible stainless steel wires adjacent to the dilatation balloon. Those wires focus the balloon's dilatation force to create two longitudinal expansion planes in the coronary plaque and stabilize the balloon across the target lesion. The device has a short, 12 mm guide wire lumen that facilitates rapid, single operator exchanges.