CD&Ds

Ekos (Bothell, Washington) has launched a device that it says provides a safer, faster and more complete way to remove dangerous blood clots. According to the company, the recently FDA-cleared EkoSonic endovascular system (ES) with Rapid Pulse Modulation (RPM) is the only endovascular system that can deliver microsonic energy and thrombolytic drugs simultaneously, with no evidence of thrombus breakage or hemolysis.

Robert Hubert, president/CEO of Ekos, told Cardiovascular Devices & Drugs that the EkoSonic stands out from other endovascular systems on the market because most of these other devices are mechanical and therefore not as safe as the EkoSonic ES. He said that Ekos' technology avoids hemolysis, a complication often associated with lengthy mechanical procedures and associated with kidney failure complications.

"Unlike mechanical devices, Ekos technology does not fracture the thrombus or damage red blood cells," Hubert said. "Faster clot dissolution means a lower lytic drug dosage, resulting in fewer complications. Physicians can treat patients in less time, with even greater clinical confidence."

The technology uses ultrasound to temporarily loosen and separate the fiber of the blood clot — the fibrin — for more blood clot permeability, according to Ekos. The ultrasound also helps push the drug deep into a blood clot to accelerate thrombolysis and dissolve the clot, the company said.

Using ultrasound to open up and dissolve blood clots is a technique that has been studied for four decades, Hubert said. Ekos has developed a way to miniaturize the ultrasound devices that are embedded inside the catheter, he said. Also, the catheter itself is an "intelligent drug-delivery catheter," which he described as designed to automatically sense what is happening during its use in real time.

The company's EndoWave device — an earlier generation of the technology — has been on the market for two years, Hubert noted. The difference between it and the EkoSonic is that the new device offers the RPM strategy, a new method of attacking the clot by disrupting it two times faster than the EndoWave and four times faster than conventional catheter-directed thrombolysis.

In addition to its RPM technology, the EkoSonic ES design features an advanced control unit with an easier, more intuitive user interface, making set-up and operation simple, EKOS said. EkoSonic ES is also compatible with the EkoSonic Mach 4.

The EkoSonic system is FDA-cleared for controlled and selective infusion of physician-specified fluids, including thrombolytic, into the peripheral vasculature. It is used to treat patients with peripheral arterial occlusions and deep vain thrombosis.

The company says the technology also may some day change the way ischemic stroke patients are treated. In 2006 Ekos received a grant from the National Institute for Neurological Disorder and Stroke, a division of the National Institutes of Health, to develop an ischemic stroke therapy that provides faster restoration of blood flow to the brain tissue.

Ekos said pre-clinical studies demonstrated that the addition of ultrasound contrast agents to ultrasound accelerated enzymatic thrombolysis and so could significantly augment the rate of clot lysis.

Elsewhere in the product pipeline:

• Acusphere (Watertown, Massachusetts) reported that the new drug application for approval to market its lead product candidate, Imagify (perflubutane polymer microspheres for injectable suspension), has been accepted for review by the FDA. Imagify is an ultrasound imaging agent for the detection of coronary artery disease. Imagify is the first ultrasound imaging agent designed to assess blood flow in the heart (myocardial perfusion), a sensitive marker of coronary artery disease. The company believes it is the first ultrasound imaging agent to demonstrate in large clinical trials clinically equivalent accuracy to nuclear stress testing, the current standard for assessing myocardial perfusion. Acusphere is a specialty pharmaceutical company.

• AngioDynamics (Queensbury, New York) reported results from its RAPTURE study, which was conducted to identify the feasibility, efficacy and safety of percutaneous radiofrequency ablation (RFA) of malignant lung tumors. Published in The Lancet Oncology July issue, the results show a high proportion of sustained, complete tumor response after treatment with RFA. The procedures in this study were performed with a 150—200 watt AngioDynamics RITA Medical Systems Model 1500 and 1500X generators with an expandable AngioDynamics RITA StarBurst XL radiofrequency ablation system. AngioDynamics is a provider of devices used by interventional radiologists, surgeons, and other physicians for the minimally invasive treatment of cancer and peripheral vascular disease.

• AngioScore (Fremont, California) reported the launch of new longer and larger AngioSculpt PTA scoring balloon catheters for the treatment of peripheral artery disease (PAD). The new devices have received FDA clearance to market for the dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, and infra popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The PTA catheter is not labeled for use in the coronary or neuro-vasculature. The new AngioSculpt devices incorporate longer (40 mm) balloons and scoring elements in the larger- diameter (4.0 mm and 5.0 mm) balloons. These new sizes are expected to be particularly useful in treating long and diffuse lesions typically encountered in the treatment of complex PAD. AngioScore makes angioplasty catheters for use in the treatment of cardiovascular disease.

• ATS Medical (Minneapolis) said it has obtained new in vivo data to support the wear characteristics of the ATS Open Pivot Mechanical Heart Valve. The first ATS Open Pivot valve was implanted in Lausanne, Switzerland, in May 1992. The patient was 70 at the time of his surgery and enjoyed another active 15 years with his ATS Open Pivot valve. He recently died of non-valve-related causes and his physician and family permitted the explantation of his Open Pivot valve for scientific analysis. Scanning electronic microscopy and laser profilometry were used to quantify the wear on the carbon portion of the valve. After 15 years of use and an estimated 560 million opening and closing cycles, the Open Pivot valve displayed no detectable wear. ATS Medical makes cardiac surgery products.

• Biotronik (Lake Oswego, Oregon) reported the release of the Stratos LV cardiac resynchronization therapy pacemaker (CRT-P). Stratos LV is a CRT pacemaker — a device which provides low-voltage stimulation for resynchronization therapy, but not defibrillation. CRT devices are indicated for certain types of heart failure patients and may improve the pumping action of the heart by helping to synchronize the heart's lower chambers (the ventricles). Stratos LV offers a feature to help assure that resynchronization therapy is delivered continuously with RVsense Triggering. RVsense Triggering helps maintain resynchronization by forcing the pacemaker to pace the left ventricle whenever there is activity in the right ventricle (whether it is a paced event or the heart beats on its own). This assures that there will be no "one-sided" cardiac activity, and may help to preserve ventricular ejection fraction (a standard measure of the heart's ability to pump blood efficiently), reduce symptoms of heart failure, and synchronize ventricular intrinsic contraction within 2.5 ms of a sensed or paced event in the right ventricle. Biotronik is a cardiovascular medical device company.

• CardioTech International (Wilmington, Massachusetts) said that it has received FDA approval to export its 4 mm graft in further support of the ongoing European clinical trial of CardioPass, the company's synthetic coronary bypass graft. CardioPass is designed to be an alternative for patients who have undergone repeat procedures or have insufficient native vessels for bypass. Repeat surgeries account for up to 20% of all bypass procedures. CardioPass is made from ChronoFlex, the company's biodurable medical-grade polymer and engineered to be pulsatile, biostable, torque-resistant and suturable. Once it is implanted, the graft's polymer construction allows it to incorporate the patient's own cells and tissue, so that the inner surface mimics the normal environment for blood contact. CardioTech International makes biomaterials for a broad range of medical devices.

• CryoLife (Kennesaw, Georgia) reported that positive mid-term performance data on the CryoValve SG decellularized pulmonary human heart valve were presented June 28 at the Western Thoracic Surgical Association meeting in Kona, Hawaii. The results showed that there was a statistically significant reduction in structural valve deterioration in patients who received the CryoValve SG for right ventricular outflow tract reconstruction procedures (RVOT) as compared to the conventionally processed valve. Valvular insufficiency occurs when the valve leaflets do not completely seal when the valve is closed, causing regurgitation, or the backward flow of blood into the heart chamber. The CryoValve SG pulmonary human heart valve is indicated for the replacement of diseased, damaged, malformed or malfunctioning native pulmonary valves. The valve can be used in conjunction with RVOT, commonly performed in children with congenital heart defects. CryoLife specializes in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries.

• eCardio Diagnostics (The Woodlands, Texas) reported the launch of an extended monitoring device, the eTriggerPLUS, in conjunction with an extended monitoring service (EMS). Extended monitoring devices provide real-time data analysis allowing physicians to capture daily ECG information through pre-defined and programmable intervals. The eTriggerPLUS is the first generation of extended monitoring devices offered by eCardio. The single component device contains features such as the eTimer automatic data capture which expands the flexibility of the eTriggerPLUS for use in various patient therapies or clinical study applications such as: device monitoring, post-ablation follow-up, drug titration, and the documentation of abnormal cardiac function. eCardio Diagnostics makes products for the diagnosis, monitoring and subsequent clinical management of cardiac arrhythmias, predominantly in the ambulatory setting.

• Neoprobe (Dublin, Ohio) said it has introduced an enhanced gamma detection control unit, the Neoprobe GDS (Model 2300), in connection with the company's marketing partner, Ethicon Endo-Surgery. The Neoprobe GDS control unit contains internal circuitry that enables it to communicate with Neoprobe's other wireless probes without the necessity of an external adapter. Neoprobe's wireless probes are available with either straight or angled tips and can also be used with all previous models of the company's neo2000 control unit (Models 2000, 2100 and 2200) using an external serial port adapter. Neoprobe makes oncology and cardiovascular surgical and diagnostic products.

• NewCardio (Santa Clara, California) reported the results of its second external validation study of QTinno (the NCE2 Study). The study was led by an independent industry leading cardiac safety expert with extensive experience in pharmaceutical clinical trials. The NCE2 study evaluated the accuracy, precision and speed of NewCardio's lead product, QTinno, in producing fully automated measurements of drug-induced QT prolongation, a key cardiac safety indicator. QTinno is a software suite that provides automated, comprehensive analysis of QT intervals and other ECG-based cardiac safety for the pharmaceutical industry and drug regulators. NewCardio is a cardiac diagnostic and services company focused on the development of a proprietary platform technology to provide higher accuracy to, and increase the value of, the standard 12-lead ECG.

• Radi Medical (Uppsala, Sweden) reported improvements to its latest-generation pressure-sensing guide wire, PressureWire Certus. The upgraded PressureWire Certus features a new ergonomically designed proximal connector which provides three key advantages for physicians. The new entry funnel allows for wire reconnection into the proximal connector, while also exhibiting less insertion friction. In addition, the new locking cap provides positive reinforcement when the wire and the connector are locked in place via a user intuitive on and off twist function. Radi Medical specializes in interventional cardiology products.

• Summit Doppler Systems (Golden, Colorado) introduced an upgrade to the Vista AVS, a full-featured arterial physiologic exam system. The new Vista AVS has advanced features, one of which allows clinicians to perform the ankle brachial index (ABI) exam for the diagnosis of peripheral arterial disease (PAD) in the seated position, the patent-pending Seated ABI. The ABI exam, which compares systolic blood pressures obtained at the ankles and arms, was traditionally performed with the patient in the supine position to prevent error from hydrostatic pressure. This position requirement made the exam difficult for patients with disabilities or mobility impairments. Recent studies have shown these patients have reduced access to many diagnostic exams. The new Vista AVS calculates ABI values for seated patients by compensating for the effects of gravity on the lower extremity pressures. Now for the first time, patients who are immobile or unable to lay supine can be seated for ABI measurement. Summit Doppler Systems makes ultrasound Doppler products.