A Swiss firm has developed a new non-invasive, portable device that delivers, in a proprietary manner, low-voltage stimulation impulses to the patient's skeletal muscles through adhesive electrodes to improve the efficiency of even the most damaged hearts. Development-stage firm CardioLa (Winterthur, Switzerland) calls its new technology Muscular CounterPulsation (MCP), a short form of "electrical stimulation of skeletal muscles in counterpulsation mode," with this stimulation performed in synchronization with the heartbeat. MCP has been shown to significantly unload the heart and improve the patient's hemodynamics by augmenting early diastolic pressure and reducing afterload, thus increasing overall cardiac efficiency, according to the company.
"Most importantly, a reduction in systemic vascular resistance has also been demonstrated with MCP," Christian Stuerzinger, president and chief executive officer of CardioLa, told Cardiovascular Device Update. "Reduction in systemic resistance reduces the heart's workload, as the left ventricle has less to push against and eventually leads to improved pumping function of the heart." MCP also helps give the heart more energy by increasing the blood flow to the heart muscle itself. "But that's just a small part of the story," Stuerzinger said, citing examples of patients able to walk who were previously unable to, as well as general improvements in the quality of life of cardiac patients treated with the system.
The device has received CE marking, and Stuerzinger reported more than 700 patients treated in Europe since 1990. The next step, he hopes, is to find strategic partners to pursue large-scale clinical trials and commercialization, notably in the U.S. "This is our objective," he acknowledged, but one that should prove realistic in light of the positive experience of other, more expensive and bulky counterpulsation systems on the market today.
Stuerzinger said that a key advantage of the CardioLa MCP system is its small size, ease of use and portability. The size of a laptop, it weighs just three pounds, which could be reduced further in large-scale production. Electrical pulses are generated through adhesive electrodes attached to the skin near areas "known for muscle stimulation, typically, the muscles of the lower belly, thigh or lower calf," Stuerzinger said. For synchronization with the patient's heartbeat, the device is connected to a standard ECG machine.
He emphasized the simplicity of CardioLa's approach in two ways besides its portability, the device "is using a normal part of the body's mechanism of muscle reaction to trigger these effects." In addition to the benefits of external counterpulsation, MCP also provides the advantages of conventional transcutaneous muscle stimulation, quite important since the treatment of cardiovascular diseases is increasingly seen as also involving skeletal muscle therapy. Because it unloads the heart, MCP can be performed without harming the patient.
Elsewhere in the product pipeline:
Abbott Laboratories (Abbott Park, Illinois) said that its manufacturing partner, Axis-Shield (Dundee, Scotland), has submitted a premarket notification 510(k) application to the FDA seeking clearance of a B-type Natriuretic Peptide (BNP) test for use on Abbott's AxSYM automated immunoassay instrument system. BNP is a cardiac marker used in the diagnosis of heart failure.
Amersham plc (London, UK) said that the findings of a Duke University (Durham, North Carolina) study abstract, reported at the American Heart Association meeting in November, indicated that the use of Visipaque (iodixanol) was found to have a significantly lower incidence of in-hospital major adverse cardiac events (MACE) compared to Isovue (iopamidol) in patients who undergo an interventional therapeutic cardiac procedure. Visipaque is a nonionic, isosmolar contrast medium used to provide enhanced X-ray images of soft tissues for the diagnosis of many common diseases. The data of the Visipaque vs. Isovue in Cardiac Catheterization trial show a significantly lower incidence of cardiac complications following percutaneous coronary intervention (PCI) procedures using Amersham's Visipaque, when compared to the low osmolar, nonionic, contrast medium Isovue. The data show that patients receiving Visipaque experienced fewer MACE when compared to patients receiving Isovue in the 48-hour period immediately following PCI.
Boston Scientific (Natick, Massachusetts) has received approval from the Japanese Ministry of Health, Labor and Welfare to market its Express coronary stent system. The company plans to launch the product in Japan this month, after it is approved for reimbursement. The Express system was launched last year in the U.S., Europe and other international markets. The company also said that it has received confirmation from the FDA of the schedule for inspections of manufacturing facilities in Galway, Ireland, and Maple Grove, Minnesota, in connection with the premarket application for its TAXUS Express paclitaxel-eluting coronary stent system. The inspections are currently scheduled for early this month in Galway and early February in Maple Grove. The company said it expects that all requirements for approval of the product will be met in 1Q04.
Cardiac Science (Irvine, California) said it was granted a U.S. patent that covers a publicly available portable automated external defibrillator (AED) capable of being used by a bystander to automatically deliver life-saving defibrillation to a heart attack victim. The issuance of U.S. patent No. 6,658,290, titled "Public Access Defibrillator," is a prelude to the 1Q04 launch of the company's fully-automatic version of its Powerheart AED G3.
Carmeda AB (Upplands V sby, Sweden) said that Berlin Heart AG's (Berlin, Germany) implantable Incor axial-flow blood pump with the Carmeda BioActive Surface has effectively supported a patient for 520 days. The pump has been used in more than 80 cases with an average treatment of 111 days, according to Berlin Heart, and its Carmeda-coated Excor paracorporeal pump has provided support in a 72-year-old patient for more than three years. The Carmeda surface is a proprietary heparin coating that retains thromboresistant properties for periods lasting several months.
CardioGenesis (Foothill Ranch, California) said it is continuing to work with the FDA on the interactive review of the company's premarket approval (PMA) supplement for the Axcis percutaneous myocardial revascularization (PMR) system, which is now expected to be complete in January. The FDA's Office of Device Evaluation has informed the company that it believes the data in the amended PMA supplement is still not adequate to support approval of the angina-relieving PMR system. In the next step of the process, the company will respond to the issues that were raised by the agency. If a favorable outcome cannot be reached as a result of the interactive review process, a hearing before the FDA's Medical Devices Dispute Resolution Panel remains an option for the company.
Endologix (Irvine, California) reported that follow-up findings, presented at the Veith Symposium in New York, from a Phase II study of the company's PowerLink endoluminal stent graft for the treatment of abdominal aortic aneurysm lends evidence of the durability of the device's clinical results. Of the 154 patients in the Endologix PowerLink System pivotal trial who have been monitored for a minimum of one year, the PowerLink was safely deployed in 151 patients (98%), with no device-related deaths during the perioperative period. The findings indicate a one-year endoleak rate of 5.8%, which the company said compares favorably with currently marketed devices. No device-related aneurysm ruptures, wire fractures or material failures associated with the PowerLink System were reported during the follow-up period. Endologix expected to file a full premarket approval submission for the system with the FDA by the end of December.
EP MedSystems (West Berlin, New Jersey) reported that its Alert CS (Coronary Sinus) deflectable catheter has received the CE mark for sale in the European Union. A deflectable catheter allows the physician to deflect its tip to steer the catheter into certain vessels and areas of the heart. The Alert System delivers programmable low energy bi-phasic electrical impulses directly to the inside of a patient's heart to convert atrial fibrillation to a normal rhythm. The electrical impulses are delivered via the Alert catheter used in tandem with an energy source called Alert Companion.
IDev Technologies (Houston, Texas) received FDA clearance to market the Texan foreign body retrieval device in the U.S. The device is indicated for use as a tool to retrieve and manipulate foreign bodies from distal peripheral vessels of the cardiovascular system. The Texan is guidewire-compatible and features a variable, radiopaque loop design, which allows for loop size adjustment during the procedure and within the vessel.
IntraLuminal Therapeutics (Carlsbad, California) has received 510(k) clearance from the FDA to market its peripheral Safe-Cross Total Occlusion Crossing System. The system is designed to give the interventionist real-time feedback as to the proximity of the crossing wire to the arterial wall, plus the capability to use radiofrequency power on the tip of the wire, to assist in penetrating hardened material within the artery. It facilitates safe passage and placement of therapeutic devices for recanalization in native iliac and superficial femoral peripheral arteries. The company anticipates U.S. market launch in 1Q04.
Medtronic (Minneapolis, Minnesota) reported market introduction in Europe and Canada of the Medtronic Advantage Supra bileaflet mechanical aortic heart valve. Its supra-annular design allows a larger valve to be implanted, thereby optimizing blood flow, a key to reducing the workload on the heart and improving patient outcomes, the company said. The Advantage Supra valve joins Medtronic's standard Advantage mechanical valve in offering SureFlow Technology, a proprietary design engineered to facilitate implantation and optimize blood flow across the valve and through its pivot region. The new Supra model features a polyester sewing cuff shaped to allow the valve to be sutured in place completely above the natural aortic valve position. This allows the valve's two leaflets to open and close outside and above the confines of a small aortic root or in other anatomical situations where flow would be compromised by standard valve placement.
Possis Medical (Minneapolis, Minnesota) reported at its annual shareholder meeting that it planned to launch a rapid exchange version of its flagship XMI catheter, XMI-RX, with initial labeling for use in removing blood clots from peripheral arteries in the legs. The company's AngioJet catheters have previously been sold in an "over the wire" configuration, and the new version is better aligned with physician preference. The company also has filed a premarket approval supplement with the FDA seeking coronary labeling of the XMI-RX. It is expected to be available to all accounts in Possis' fiscal third quarter.
Sorin Biomedica (Sallugia, Italy) said its InPeria Carbostent the only stent approved for endovascular procedures in below-the-knee arteries has been the subject of a preliminary clinical study involving the treatment with angioplasty of a group of patients with a high incidence of diabetes. After one year of follow-up, the patients treated with a stent showed a marked improvement in vessel perviety. This multi-center pilot randomized study demonstrated significant long-term clinical results in the reduction of the degree of claudication. The use of the InPeria stent in the treatment of infrapopliteal occlusions produced better results in improving the conditions of the lower limbs than traditional treatment methods, the company said.
St. Jude Medical (SJM; St. Paul, Minnesota) provided an update on the status of its planned regulatory filings to the FDA for the RHYTHM (Resynchronization Hemodynamic Treatment for Heart Failure Management) implantable cardioverter defibrillator (ICD) study. The RHYTHM ICD study is a multiphase premarket approval trial, including an initial on/off randomized phase studying the St. Jude Medical Epic HF ICD with the Aescula 1055K stylet-driven lead system in heart failure patients; a second phase which studies the Quicksite1056K over-the-wire lead system; and a third phase which studies the programmable V-V timing feature of this product line. In order to incorporate the clinical data for the Quicksite 1056K lead into this submission, St. Jude said it planned to submit its filing to the FDA by mid-December. Separately, the company reported European CE mark approval and the first implant of the SJM Epic Supra bioprosthetic aortic heart valve. Building on the SJM Biocor valve design that the company said has a documented 17-year track record of durability and reliability, the SJM Epic and Epic Supra valves offer the added benefit of the St. Jude Linx anticalcification technology. The SJM Epic Supra valve addresses the need for a highly implantable supra-annular stented porcine tissue valve in patients with smaller aortic roots. The first implant of the SJM Epic Supra was performed by Dr. Lars Thulin at the University Hospital (Lund, Sweden). A limited European market launch for the SJM Epic Supra valve is under way, with full market availability in 2Q04.
Thoratec (Pleasanton, California) said the FDA approved its premarket approval supplement to market the TLC-II Portable Ventricular Assist Device (VAD) Driver for home discharge. The TLC-II is a small, lightweight device used to power the Thoratec VAD, as well as the investigational IVAD (implantable VAD), which pump blood to the body in heart failure patients awaiting transplantation or recovery from open-heart surgery. It is the first biventricular support device to receive such approval, the company said.
Vascular Solutions (Minneapolis, Minnesota) has received CE mark approval for internal manufacturing of the disposable probe used with its Acolysis therapeutic ultrasound product. In 2002, the company acquired the Acolysis business and inventory as a treatment for peripheral vascular disease. At the time of acquisition, the Acolysis product already was commercially available in Europe; however, Vascular Solutions' manufacturing of new probes required the creation, testing and CE mark approval of its own manufacturing processes.