CD&Ds

Cardiac catheter ablation is commonly used to treat rhythm disorders, but physicians have been forced to estimate the level of contact force required. Too little may render the procedure ineffective and too great a force may perforate the heart wall.

Endosense (Geneva, Switzerland) last month launched a first-in-human study of its TactiCath force-sensing catheter that will guide physicians so that they can use optimal contact force for the appropriate lesion creation in a catheter ablation procedure.

"We believe this procedure may allow the standardization of this technique and enable 6 million patients around the world to benefit from the therapy who are just waiting for the right technology to expand," President/CEO Eric Le Royer, told Cardovascular Devices & Drugs. "It's our proprietary technology and clearly physicians are interested. We know that we'll be the pioneers."

Endosense has launched the TOCCATA (TOuCh+ for CATheter Ablation) clinical study to evaluate the safety of TactiCath. The 70-patient European multi-center safety study is designed to gain CE-mark approval for the treatment of atrial arrhythmias. Secondary endpoints were designed to evaluate the value of force-sensing in successfully impacting outcomes of the ablation procedure.

The TactiCath is an 8.5 Fr sheath-compatible, open-irrigated, steerable catheter that integrates Endosense's Touch+ fiber-optic sensor technology at the catheter tip.

Prior to the launch of this study, 11 patients have been treated thus far by different investigators, including Endosense European scientific advisors Karl-Heinz Kuck, MD, at St. Georg Hospital (Hamburg, Germany) Dipen Shah, MD, University Hospital of Geneva (Switzerland) and Nadir Saoudi, MD, at Princess Grace Hospital (Monaco). Those patients had different arrhythmia pathologies, including atrial fibrillation.

Le Royer said that all of the patients were treated successfully, giving the company momentum to push forward with the TOCCATA study.

Catheters have been used for years to deliver radiofrequency energy to create a scar or ablation line which electrically isolates the partially damaged heart muscle from the surrounding healthy muscle, preventing abnormal electrical signals. TactiCath simply refines the technique, giving physicians a real-time, objective measure of contact force during the procedure.

"Trying to navigate in the 3-D cavity is a quite a challenge in a beating heart, to assess if the right force is being used," Le Royer said. "If too much force is used, a perforation may occur. If there's not enough force, you may do a superficial lesion or the wrong one. It's a balancing act between act between excessive and insufficient force."

Assuming a positive outcome from this safety study, Endosense will immediately proceed with commercialization plans in Europe, and then consider starting trials in the U.S., seeking FDA clearance via a PMA.

Endosense is a venture capital-funded company with no major partnerships. But Le Royer told CD&D that as TactiCath moves forward in the development cycle, future partnerships with med-tech companies are "an option" he'll consider.

Elsewhere in the product pipeline:

  • Berlin Heart (Berlin, Germany) said that its Excor pediatric ventricular assist device (VAD) has received unconditional approval for the ongoing IDE clinical trial in the U.S. The Excor is a mechanical cardiac support system for critically ill pediatric patients suffering from severe heart failure. Unlike standard heart-lung machines, Excor Pediatric has been used as a short-term, mid-term and long-term support system, supporting failing hearts from days up to several months. The system is designed to bridge patients awaiting heart transplantation until a donor heart becomes available, but also has been used successfully as a bridge to recovery when a patient's heart was able to recover and work on its own again.
  • Boston Scientific (Natick, Massachusetts) said in early October that it had received FDA approval to market its second-generation Taxus Liberte paclitaxel-eluting coronary stent system in the U.S. The company said it plans to launch the stent in November, following completion of the introduction of its Taxus Express2 Atom paclitaxel-eluting coronary stent, which received FDA approval in September. "The Taxus Liberte stent represents our latest advance in drug-eluting stent technology," said Donald Baim, MD, chief medical and scientific officer for Boston Sci. "This device has substantially thinner struts and a more flexible cell geometry for improved deliverability, as well as uniform strut distribution designed specifically for drug elution." He said the Taxus Liberte stent "demonstrated similar late loss and target vessel revascularization as the Taxus Express2 stent system in the ATLAS Workhorse clinical trial, despite treating more challenging patients." Boston Scientific said the Taxus stent systems "have been evaluated by the industry's most extensive randomized, controlled clinical trial program, with follow-up to five years in some cases. These trial results have been supplemented by data on more than 35,000 patients enrolled in post-approval registries."
  • CardioNet (Conshohocken, Pennsylvania) reported the release of its new atrial fibrillation (AF) reporting package to enhance its current AF Management Program. The program offers a tool to the physician for the diagnosis, treatment and management of their AF patients. The program additionally provides physicians with a monitoring program to evaluate the clinical efficacy of catheter and surgical ablation procedures allowing improved management of these post surgical patients.
  • eCardio Diagnostics (The Woodlands, Texas) reported the rollout in early October of its newest product, eVolution, a single-component cardiac monitoring system providing data concerning the heart's rhythms, automatically, on an ambulatory basis and with no need for patient activation or other compliance. eVolution is designed to provide the advantages of both home-based and ambulatory systems, according to the company – or, conversely, avoid the disadvantages of both, thus indicating a clear advance in this technology and the basis for the name. Rachael Moore, director of marketing and communications for eCardio, told CD&D that eCardio provides "the whole gamut, from Holter monitoring to this daily extended device." She said that Holter monitoring "has been around for the last 50 years," but the company has now is able to move beyond this traditional modality "to the new eVolution." The specific advantages are that the system offers the long-term, continuous assessment provided by home-based monitors, but with a single small device – and enabling the type of patient mobility usually related to Holter systems, but even more flexible and patient-friendly. Moore noted that the eVolution provides this monitoring automatically, requiring no patient compliance – such as pressing a button or other action to send a data message. At the same time, the patient can send a message, if necessary, indicating some problem, with the push of a button or over a phone line. Robert Jordan, executive vice president of the company, said the system essentially works as "a first set of eyes" to track the patient's heart function, whether indicating normal operation or signaling a problem and the need for some intervention. eVolution records and transmits cardiac rhythm events to eCardio's 24-hour monitoring center in Houston, and with what the company calls "an exclusive auto-detecting algorithm" and micro-processor, the device provides real-time data analysis via digital rather than traditional analog technology. Jordan explained that the waveform data is then translated by a certified cardiographic technician to create a physician report which is transmitted daily to a secure website which the physician can access from any PC. In case of receiving a transmission indicating abnormal activity, an Internet "action report" transmission is then followed by a phone call to the doctor, alerting him to check the website, with both technician report and waveform, to determine if intervention is required.
  • HeartWare (Framingham, Massachusetts) said that it has received full approval from the FDA of an investigational device exemption for the HeartWare Left Ventricular Assist System (LVAS). HeartWare said in May that it had received conditional approval from the FDA for a U.S. clinical trial of the HeartWare LVAS for use as a bridge to cardiac transplant in patients suffering from end-stage heart failure. This conditional approval permitted the company to start its U.S. trial, but included several conditions which HeartWare was required to address to the FDA's satisfaction.
  • Integrated Medical Systems (IMS; Signal Hill, California), a developer of integrated products for critical care, reported FDA clearance for its MedEx 1000 "suitcase" intensive care unit (ICU). The MedEx 1000 is a portable unit intended to supply ICU functions for adult and pediatric patients, combining several medical device capabilities in a single platform: physiological monitoring (electrocardiogram, invasive pressure monitoring, non-invasive blood pressure monitoring, temperature, blood oxygen saturation, and heart rate); low-rate and high-rate infusion pumps; a fluid warmer; a ventilator with carbon dioxide monitoring capabilities; and the ability to deliver oxygen. The functions of the MedEx 1000 are controlled from a central user interface; it may be operated using either hot-swappable battery power or an external source. The unit can accept external high-pressure or low-pressure sources of oxygen. The MedEx 1000 is intended to be used in hospitals, aircraft, ambulances, field hospitals, and extended care facilities.
  • OBS Medical (Carmel, Indiana) reported FDA clearance for its Visensia Alert (VitalAlert) in the U.S. Formerly know as BioSign, Visensia's automated early warning technology fuses up to five vital signs – heart rate, respiration rate, body temperature, oxygen saturation and blood pressure – into a numerical index. The Visensia Index is an indication of a patient's wellness and can enable significant improvement in clinical outcomes and optimization of hospital resource utilization. When the Index reaches and/or surpasses the default threshold, the VitalAlert is triggered.
  • Physio-Control (Redmond, Washington), a subsidiary of Medtronic (Minneapolis), has developed the LifePak 20e defibrillator/monitor, which displays the real-time status of available battery capacity and a fuel gauge, so that clinicians can monitor remaining use time more closely. "We are very pleased to have received 510(k) clearance from the FDA on the LifePak 20e defibrillator/monitor," said Brian Webster, president of Physio-Control. "[We have] a long history of providing products for the hospital marketplace and the 20e will fit well into the line of reliable, quality products customers have come to expect from us." The device is actually an enhancement to the LifePak 20, which has been widely in use since 2002. It is powered off more powerful Lithium-ion battery and is said to double the ECG monitoring time. The device also was developed to be easily transported, helping hospitals meet the Joint Commission standard for having resuscitation services readily available in all facility areas.
  • Synvista Therapeutics (Montvale, New Jersey) in late September reported favorable findings from a study that indicated its proporietary monoclonal enzyme immunoassay can help in predicting cardiovascular risk in patients with diabetes. The findings were presented at the Cardiovascular Biomarkers and Surrogate Endpoints Symposium in Bethesda, Maryland. In the study, investigators developed an ELISA (enzyme-linked immunosorbent assay) using a monoclonal antibody that differentiates between the three haptoglobin pheno/genotypes. Blood samples from diabetic patients with known haptoglobin pheno/genotypes were tested using Synvista's proprietary methodology. Results demonstrated 99.5% accuracy in determining each of the three haptoglobin types (48/48 Hp 1-1, 49/49 Hp2-1 and 90/91 Hp-2-2) with a =98% sensitivity and specificity for each phenotype. The company said the ELISA assay was developed using a monoclonal antibody that can differentiate between each of the three Hp phenotypes. Serum samples from diabetics of known phenotype/genotype were diluted 1:10 and incubated in microtiter strips coated with an anti-human Haptoglobin monoclonal antibody for 30 minutes. The strips are washed and incubated for 30 minutes with monoclonal anti-human Haptoglobin conjugated to horseradish peroxidase. The strips are washed and developed with TMB, a peroxidase substrate, for 15 minutes. The absorbance is read on a plate reader at 450 nm. Positive controls for each phenotype also are run to ensure the assay is performing properly. Cutoffs for each phenotype are set for each lot of strips and conjugate. Haptoglobin, a core component of the immunoassay, is found in humans and comes in the form of three different proteins that arise from one of three gene combinations in the population, Hp 1-1 (16%), Hp2-2 (36%) and Hp1-2 (48%). For a variety of reasons, Hp2-2 is more effective than Hp1-1 at preventing hemoglobin-induced oxidation in the bloodstream and blood vessel wall. As a result, scientists have determined that the rate of heart disease is five times higher in Hp2-2 diabetes than in Hp1-1 diabetes. Hp2-2 diabetes also has higher rates of myocardial infarction and re-vascularization within one year of angioplasty, and of heart failure and death following a heart attack.

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