Biotronik (Berlin, Germany) last month became the second company to receive FDA approval for a dual-chamber implantable cardioverter defibrillator (ICD) device for the treatment of atrial fibrillation (AF). Its Tachos DR-Atrial Tx ICD received a 510(k) approval for commercial release after an initial submission back in March.
The private company thus joined Medtronic (Minneapolis, Minnesota) in this sector. That device powerhouse won first approval for this type of device when its GEM III system was approved in December 2000. The GEM III is the device with which Vice President Dick Cheney was implanted in July 2001.
Biotronik's device is designed for patients who require therapy for the treatment of life-threatening ventricular tachyarrhythmias (VT) with coexisting atrial tachyarrhythmias (AT) or are at risk of developing ATs. These combination systems are designed to treat both AF, too-rapid heart rhythms in the upper chamber of the heart, and VT (the condition with which Cheney was diagnosed), too-rapid heart rates in the lower chambers of the heart.
In addition to providing effective ventricular therapy, the company said the system features multiple options to terminate atrial arrhythmias including pacing, high-frequency burst and shock therapy in AT and AF detection zones.
Biotronik said its TACT (Tachos Atrial Conversion Therapy) study showed that the device painlessly converts arrhythmias with high-frequency burst therapy in over 43% of atrial fibrillation episodes – a substantially higher success rate, it claimed, than has been achieved by any other commercially available device.
Dan Dahlke, senior manager for field clinical engineers and technical services at Biotronik's U.S. headquarters in Lake Oswego, Oregon, said Medtronic's GEM III has the ability to deliver only three-second bursts of energy. He said that company's studies showed "about a 16% or 17% efficacy in treating atrial arrhythmias." He told Cardiovascular Device Update that the Biotronik system can deliver shocks of up to 29 seconds, but that the most effective range for treatment "is between five and seven seconds."
With up to 32% of all ICD recipients developing atrial tachyarrhythmias, these indications suggest that tens of thousands of patients may benefit from an ICD with atrial therapies, the company said.
A critical feature of the system is something the company calls the SMART Detection Algorithm. Biotronik says this detection algorithm is designed to discriminate between ventricular tachycardias and supraventricular tachycardias.
Other competitive features include 32 minutes of fully annotated, dual-chamber stored heart rhythm recordings, accelerometer-based rate-adaptive pacing, back-up pacing for all atrial therapies, Mode Switching and an extensive diagnostic package.
Dahkle said Biotronik probably would price the Tachos system slightly under the GEM III. "We'll still get a premium price for it," he added, also noting that the company is still in the process of finalizing its labeling for the device.
The system has been approved for sale in Europe for a little over two years.
Elsewhere in the product pipeline:
Ark Therapeutics (London) began clinical trials of EG010, a point-of-care test kit for cardiovascular disease. The kit measures oxidized-low density lipoproteins (Ox-LDL), which are found in the fatty plaques that line the walls of the coronary artery in patients with atherosclerosis, but not in healthy coronary arteries. In a previous study in Finland, the EG010 test demonstrated a significant correlation between levels of Ox-LDL and the severity of a patient's heart disease.
Bioheart (Weston, Florida) received FDA authorization to enroll 15 patients in a Phase I study adjunct to bypass of its investigational product, MyoCell, for heart muscle regeneration. In May, one-year results from the first MyoCell-treated patient in Europe revealed a left ventricular ejection fraction increase to 56% from a baseline of 39% in May 2001. Mid-term results on 13 patients were to be presented at last month's Transcatheter Cardiovascular Therapeutics conference in Washington. Also, Bioheart's U.S. production facility for MyoCath catheter delivery systems received ISO 9001, ISO 13485 and EN 46001 quality systems certification. The company said it expects to receive European approval for MyoCath during the first quarter of next year.
Boston Scientific (Natick, Massachusetts) received FDA premarket approval for its Express2 coronary stent system. The company said it planned 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.
Cardima (Fremont, California) submitted to the FDA a premarket approval application to market its Revelation Tx linear ablation catheter to treat paroxysmal AF. The application is the final in the module PMA process, presenting the results of the clinical study. Cardima said it intends to ask the FDA for an expedited review, with anticipated approval in the first quarter of next year. The Revelation Tx linear ablation microcatheter system is a minimally invasive, single-use system. Cardima said Phase I and II data have demonstrated safety and promising efficacy. The company said there are no other FDA-approved devices to treat the disease, a cardiac arrhythmia that affects an estimated 2 million Americans. Cardima also presented at last month's European Society of Cardiology conference in Berlin, Germany, data on a minimally-invasive approach using the Revelation Tx to create linear lesions on the outside of the heart wall to treat atrial fibrillation (AF). Preliminary results from the multicenter pivotal trial has shown 84% of patients reported a greater than or equal to 50% reduction in AF episodes and 45% of patients reported no AF episodes at the six-month monitoring period. The company said it believes its Revelation microcatheter technology has shown the ability to make continuous, linear lesions with a good safety profile. Cardima said it soon planned to submit to the FDA its premarket application for its linear ablation microcatheter, the Revelation Tx, with FDA approval targeted for the first quarter of next year.
CardioNow (Encinitas, California) released its WebSend software application that enables electronic sharing of complete cardiac studies with remote sites worldwide. WebSend complements CardioNow's Internet-based DICOM Image and Information Management Service, used by U.S. hospitals, trial sponsors and cardiovascular core labs. WebSend allows users to quickly and securely share cardiac cath, echo and intravascular ultrasound DICOM studies via the Internet from any standard PC. Studies transferred using this application are sent in their native DICOM format in near real-time with no compression or loss in resolution. Study recipients then are able to open and view studies in the original DICOM format from a review station.
Carmeda (San Antonio, Texas) reported publication in the June issue of Comparative Medicine of a paper describing benefits of its 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.
Cook (Bloomington, Indiana) received CE mark approval for its V-Flex Plus PTX Coronary Stent System, a drug-eluting stent, just days after receiving CE mark clearance to sell its Achieve Drug Eluting Stent System in Europe. Cook said it will begin selling the V-Flex Plus PTX stent in Europe immediately. The V-Flex Plus PTX, manufactured using Cook stent components with the company's proprietary polymer-free paclitaxel coating, received the approval following review by both the Medicines Control Agency and Lloyd's Register Quality Assurance. Animal testing and human clinical data from the ELUTES trial supported the regulatory submission, Cook said. Phyllis McCullough, executive vice president of operations, Cook Group, said the company has no plans at this time to introduce the V-Flex Plus PTX stent to the U.S. market. In the ELUTES trial, the V-Flex Plus PTX demonstrated a restenosis rate of 3.1% due to its paclitaxel coating.
Edwards Lifesciences (Irvine, California) re-ceived CE mark approval for a pair of heart valve therapy products, the Carpentier-Edwards Perimount Magna bioprosthesis, and the Edwards MC3 Tricuspid Annuloplasty System. Edwards called the Perimount Magna valve the world's first pericardial heart valve designed to optimize hemodynamics for an individual's anatomy. Its design combines the company's pericardial technology with a supra-annular configuration and a streamlined sewing ring to allow placement above a patient's native annulus. Edwards said its MC3 Tricuspid annuloplasty system features an annuloplasty ring modeled to fit the three-dimensional contours of the tricuspid valve's annulus. The company called the MC3 the first 3-D ring designed for surgical repair of the tricuspid valve. Engineered to conform to the tricuspid orifice, its design minimizes stress on sutures.
Geron (Menlo Park, California) published in last month's issue of Circulation Research data 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.
Guidant (Indianapolis, Indiana) completed enrollment in a company-supported optical coherence tomography (OCT) 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.
Innercool (San Diego, California) began a pivotal 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 said 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 said that the company projects receiving a clearance before year's end. That clearance would be the first for Innercool 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, the company 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.
IntraLuminal Therapeutics (Carlsbad, California) released at last month's Transcatheter Cardiovascular Therapeutics meeting in Washington its first-generation Safe-Steer system. The company called the device the first total occlusion product including guidance to be introduced in the U.S. It is designed to enhance the potential for successfully treating patients in a less invasive way than surgery. IntraLuminal said most patients will be able to leave the hospital in one to two days, instead of the five to seven days normally required with surgical treatment.
Ischemia Technologies (Denver, Colorado) received Canadian 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.
Life Medical Sciences (Oceanport, New Jersey) completed patient enrollment for the feasibility clinical trial of its Repel-CV bioresorbable adhesion barrier designed to reduce the formation of adhesions on the surface of the heart after open-heart surgery. Eli Pines, MD, clinical consultant, said the enrollment completion allows for trial completion and submission of results to the FDA during the first half of 2003. "We are very pleased with the absence of product-related safety issues as well as the favorable comments from participating surgeons regarding the handling and use of Repel-CV," Pines said. The trial is being conducted on neonatal patients in compliance with a surgical protocol designed to provide an initial assessment of the efficacy of Repel-CV in reducing adhesion formation in open-heart surgeries as well as provide additional data on the product's safety profile. The company said the product "could become the first adhesion barrier approved by the FDA for use in cardiovascular surgery."
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.
Novavax (Columbia, Maryland) said a report in the Sept. 5, 2002, issue of Stroke demonstrated that nasal administration of recombinant human E-selectin protein inhibited the development of ischemic and hemorrhagic strokes in spontaneously hypertensive, genetically stroke-prone rats by induction of mucosal tolerance. The results suggest that E-selectin tolerization may become a new treatment for human stroke. In collaboration with the National Institute of Neurological Disorders and Stroke, a unit of the National Institutes of Health (Bethesda, Maryland), Novavax has been developing E-selectin-based biological products to prevent and treat strokes.
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.
Texas Biotechnology (Houston, Texas) said Argatroban would be evaluated in combination with t-PA as a new approach to treat acute ischemic stroke, at the University of Texas Medical School (also Houston), as part of a program funded by the National Institute of Neurological Disorders and Stroke, a unit of the National Institutes of Health (Bethesda, Maryland). Results of the open-label, 20-patient trial, designed to assess the safety and efficacy of Argatroban in combination with t-PA, are expected in the first half of 2004.
Vascular Architects (San Jose, California) reported 12-month results of its combined U.S. and European clinical trials evaluating use of its aSpire covered stent and Controlled Expansion delivery system to treat superficial femoral artery (SFA) and iliac artery stenoses and occlusions. Sixty patients (63 treated legs; 35 SFA, 28 iliac) were followed for at least 12 months, for an average follow-up time of 16 months. The average lesion length treated was 13.6 cm. Technical success was 100% as all stents were successfully placed with no evidence of subsequent stent migration. Primary patency is 86% and secondary patency is 97%. When taking all patients enrolled in the trials to date (133 patients, 141 legs; 102 SFA, 39 iliac), primary patency is 90% and secondary patency is 96%, with an average lesion length of 15.9 cm and an average follow-up of 11 months. Further, when considering the 28 patients (30 legs; 12 SFA, 18 iliac) followed for at least 12 months pretreated with balloon dilatation only followed by aSpire, primary patentcy is 93% (7% restenosis), and secondary patency is 97%.
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 within the next few weeks, 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 FX miniRAIL is a low-profile, 6 Fr-compatible system that integrates two flexible stainless steel wires adjacent to the dilatation balloon.