CryoCor (San Diego, California) said it has initiated its first U.S. multi-center pivotal clinical trial under a protocol approved by the FDA to treat atrial flutter with its CryoCor Cardiac Cryoablation System. CryoCor's system is the first cryoablation device to be entered into a clinical pivotal trial in the U.S. for the treatment of atrial flutter, one of the leading causes of hospitalization due to rapid heart rhythm, the company said.
Atrial flutter is a condition created by abnormal electrical signals in the right atrium of the heart causing the heart to beat abnormally fast, leading to shortness of breath, fatigue, dizziness and fainting. The purpose of the pivotal trial is to evaluate the safety and efficacy of the CryoCor system, a minimally invasive catheter-based medical device used by a cardiologist to block conduction of these aberrant signals within the heart in order to stop atrial flutter and return the patient to a normal heart rhythm.
Formed in 2000 as a spin-off from CryoGen (also San Diego), CryoCor is a development-stage company. Its CryoCor system delivers refrigerant to the tip of an intravascular catheter. Once positioned inside the heart, the catheter can achieve temperatures below minus 80 degrees Celsius to selectively inactivate or isolate arrhythmia-inducing or sustaining tissue. This intervention can prevent rapid and irregular heart rhythms and provide a curative, minimally invasive patient procedure.
It is believed the therapeutic impact of freezing cells comes in the thawing process. As they thaw, the cells break open and die, the area of dead cells creating an insulating barrier to the unwanted electrical activity while at the same time, keeping other structures intact.
The company's clinical trial will be conducted in the U.S. at 20 clinical sites with enrollment of up to 160 patients. Upon successful completion of this study, the company said it expects to file a premarket approval (PMA) application with the FDA. Ten of the 20 proposed clinical sites also participated in the CryoCor atrial flutter feasibility study, which ended in November after successfully treating 48 patients.
In the single-armed study, the CryoCor device will be compared to the FDA's objective performance criteria (OPC) on adequate outcomes (two radio frequency catheters already have been approved for atrial flutter and their experience will serve as a benchmark for cryoablation). The standards are established for both efficacy, meaning what percentage of patients are actually cured, and safety, meaning what percentage of the patients in the week following the procedure have any adverse events. Additionally, the patients in the trial will have six months of follow-up to make sure to make they are "flutter free."
Elsewhere in the product pipeline:
Biophan Technologies (Rochester, New York), a developer of advanced biomedical technology, said its licensor for nanomagnetic particle technologies has been issued a U.S. patent covering the use of nanomagnetic particle technology on medical devices including catheters, guidewires, endoscopes and other medical devices. The patent was issued to Nanoset (East Rochester, New York), which has provided Biophan with the worldwide exclusive medical rights to the technology. The nanotechnology patents are a subset of more than 50 pending patents filed by Nanoset and Biophan. Biophan develops technologies used to make biomedical devices such as cardiac pacemakers, surgical and diagnostic tools safe and compatible with magnetic resonance imaging equipment.
Biotronik (Lake Oswego, Oregon) said the FDA has approved interactive Internet access to the Biotronik Home Monitoring early detection system. Available for both implantable cardiac defibrillators and pacemakers, it is the first early detection system for cardiac implant devices, according to the company, and is available for both implantable cardiac defibrillators and pacemakers. The system delivers automated, wireless early detection of events for cardiac rhythm management (CRM) from implantable devices linked directly to the Internet enabling the reporting of critical CRM event information for early intervention. With the newly approved Home Monitoring Web site, physicians have greater control over many aspects of the early detection reporting and data management process.
Boston Scientific (Natick, Massachusetts) said it has received the CE mark for its new coronary stent, the Liberte. The company planned to launch the stent immediately in Europe and other international markets, and in the U.S. in the second half of 2004. Boston Scientific said the Liberte stent will serve as the platform for its next-generation drug-eluting stent (DES) system. It said it plans to file an investigational device exemption with the FDA for clinical trials of its next generation DES system in the first half of 2004. "The Liberte represents a major advance in stent development," said Paul LaViolette, senior vice president and group president, cardiovascular. "It is a novel, sophisticated technology designed to greatly enhance deliverability and conformability, particularly in challenging lesions. The deliverability enhancements improve access, while the conformability enhancements allow the stent to better follow the natural contours of the vessel." Separately, Boston Scientific reported that it has completed enrollment of a clinical trial to evaluate the benefits of stenting in conjunction with embolic protection to treat carotid artery disease. The clinical trial is using the company's FilterWire EZ Embolic Protection System and Carotid Wallstent Monorail Endoprosthesis to treat patients who are at high risk for the surgical treatment of carotid endarterectomy. The single-arm clinical trial, known as BEACH, is a prospective, non-randomized trial enrolling 747 patients at 47 sites across the U.S. Some 480 patients are being studied in the pivotal phase of the trial.
Cardima (Fremont, California) has submitted an amendment to its premarket approval application to the FDA for approval to market the Revelation Tx linear ablation catheter to treat paroxysmal atrial fibrillation. The Revelation Tx system is a minimally invasive, single-use, microcatheter-based product designed to provide easy access to arrhythmia-causing tissue, creating linear lesions or restricted pathways, and restoring normal sinus rhythm to the heart using radiofrequency energy. The company said it believes that the additional data and analysis, including data obtained from an expanded patient population, provide clear and concise safety and efficacy data.
Devax (Irvine, California) reported CE mark approval for an expanded size range of its Axxess bifurcated stent system for the treatment of stenosis at coronary bifurcations. The company said it intends to market the Axxess stent in Europe in 1Q04. The Devax Axxess technology is a multi-component stent delivery system comprising self-expanding Nitinol stents specifically engineered for the treatment of coronary and vascular bifurcation lesions. The system includes a conical stent that conforms to the bifurcation anatomy and provides full access to both side branches for additional interventional procedures.
Endologix (Irvine, California) said it has filed its completed premarket approval (PMA) submission with the FDA for the PowerLink System, an endoluminal stent graft for the minimally invasive treatment for abdominal aortic aneurysms. The completed PMA application includes the clinical results from Endologix's pivotal trial as the final step in the modular PMA submission process. Endologix said it anticipates receiving FDA approval for marketing the PowerLink System in the U.S. in the second half of 2004.
Guidant (Indianapolis, Indiana) has launched its Acrobat SUV (Swivel, Universal, Vacuum) Stabilizer System for beating-heart surgery. The Acrobat SUV Stabilizer System is the next-generation addition to the established Acrobat line of stabilization devices. The system is designed to provide optimal stabilization and visibility during coronary artery bypass graft (CABG) surgeries. "Currently, beating-heart surgery accounts for 25% of all CABG procedures performed in the U.S.," said Maria Degois-Sainz, president of Guidant's Cardiac Surgery business. "With the introduction of Acrobat SUV, Guidant will strengthen its competitiveness in this important market." Beating-heart stabilization devices such as the Acrobat SUV provide surgeons with the ability to perform CABG while the heart is still beating, eliminating the need for a heart-lung machine. The system includes the Acrobat Stabilizer and the Xpose Access Device, designed to lift the heart, allowing the surgeon to position and access blood vessels.
Medicsight (London) has received FDA clearance for two of its computer-aided diagnostic products, enabling U.S. distribution for the first time. MedicHeart is a new software solution that defines and measures plaque burden, providing a more reliable prediction of future coronary disease. MedicColon is designed to replace more invasive and complicated procedures that are not without risk to the patient. The company said an application also has been made for FDA clearance of MedicLung. MedicLung will commence commercial trials with a number of medical institutions in the U.S., once approval has been granted with a view to full launch in 2Q04, the company said.
Medtronic (Minneapolis, Minnesota) reported FDA clearance and U.S. commercial release of the Medtronic EnPulse pacing system. The new system incorporates enhanced features to help physicians better manage patients with slow heart rhythms and streamline the patient follow-up process, the company said, including Search AV +, an automatic and expanded search method that senses the patient's natural heartbeats before delivering pacing therapy; Quick Look II screen, which allows clinicians to instantly access complete information about the patient's heart rhythm and pacemaker activity on a single, easy-to-understand screen; and Ventricular Response Pacing, a specialized form of pacing that may help the ventricles contract with a regular rhythm. The EnPulse dual-chamber devices can be upgraded with new therapies, allowing for forthcoming enhancements that in the future could be enabled without patient surgery through a programmer software upgrade, Medtronic said. Separately, the company said that it has begun the distribution of the Paceart System 2004 First Edition to help clinics that specialize in heart rhythm disorders improve the electronic organization of cardiac device and patient heart rate data. The new release expands the accessibility of data managed within Paceart by providing an electronic interface between the Paceart system and an array of healthcare information systems. The new export module uses XML and PDF standards for data transmission and formatting, which enables broad compatibility with and access from other systems. Medtronic also reported the market release of two new Attain left-heart delivery systems, both designed to facilitate placement of left-heart leads during implantation of CRT devices. The Attain Prevail system is the first left-heart lead delivery system in the industry to combine steerability, catheter telescoping and vein subselection in a single package. It allows the user to create multiple curve shapes without changing guide catheters, and also permits deep advancement of the guide catheter and guide wire. Its soft, tapered tip design and small size helps minimize the chance of venous trauma. The Attain Deflectable guiding catheter provides physicians with an opportunity for successful coronary sinus cannulation and left-heart lead placement. Implanters are able to vary the catheter curve to match a patient's anatomy and, once cannulation has been achieved, the Attain Deflectable provides a stable workstation for the passing of guidewires, leads and venogram balloon catheters for greater visualization of the cardiac venous anatomy. Both new delivery systems allow contrast injection through the lumen to help visualize the anatomy, especially the cardiac veins on the left ventricle. The Attain Prevail can be inserted into fixed-shape catheters to accomplish telescoping techniques, and the Attain Deflectable allows for adjustable curve reach and telescoping with a guidewire and over-the-wire lead.
MicroMed Technology (Houston, Texas) reported FDA approval of the company's request to supplement its IDE-approved destination therapy clinical trial. The supplement changes the patient randomization scheme to a 2:1 ratio of MicroMed DeBakey VAD implants to Thoratec HeartMate XVE implants. Up to 360 patients will participate in the study, with an interim patient review available once 152 patients have received the implants. In the randomized trial, Destination Evaluation Long-Term Assist (DELTA), two of every three patients participating will be implanted with the DeBakey VAD. MicroMed has reviewed this ratio of VAD usage with its 30 clinical trial sites and said it believes this format will allow for a more rapid demonstration of the DeBakey VAD's value in comparison to traditional devices. MicroMed also is conducting a bridge-to- transplant pivotal trial in the U.S.
SS&II (Manchester, New Hampshire) reported the allowance of all claims of U.S. patent publication No. 20020151924, broadly covering an angioplasty balloon with ridges mounted on its outer surface for treating occluded coronary and peripheral arteries. The balloon also incorporates a folding mechanism that shields the ridges and protects the arterial wall during delivery and withdrawal of the catheter. The ridges concentrate the balloon's dilating force and enable the opening of resistant lesions. This new design minimizes balloon stiffness, preserves the maneuverability of the device as it negotiates curved vessels, and reduces several risks, drawbacks, and length limitations associated with the use of metal ridges in presently marketed devices, the company said.
St. Jude Medical (St. Paul, Minnesota) has filed with the FDA the final module of its PMA application for its Epic HF implantable cardioverter defibrillator, the Atlas+ HF ICD, the Aescula 1055K left heart lead and the Quicksite 1056K left heart lead. The filing included the clinical report from the RHYTHM (Resynchronization Hemodynamic Treatment for Heart Failure Management) ICD study.
Synthetic Blood International (SYBD; Costa Mesa, California) said that Phase II clinical testing of Oxycyte, the company's perfluorocarbon-based blood substitute and therapeutic oxygen carrier, is scheduled to begin during the first quarter. The company said it believes that Oxycyte may be useful in treating stroke, heart attack and cancer patients and for use as a blood substitute and in organ preservation. SYBD also is preparing for preclinical animal studies of Oxycyte for newly identified applications in cardiac surgery. These studies will address the possible risk of untoward neurological effects with Oxycyte in cardiac bypass surgery.
Tepha (Cambridge, Massachusetts) reported what it called "a major step forward" in the development of absorbable elastomeric biomaterials for use in cardiovascular stents and other medical device products. The company submitted a device master file to the FDA in December for its TephELAST biomaterial, a biologically produced absorbable elastomer. The thermoplastic polymer can be processed via conventional melt and solvent processing techniques into virtually any shape or form.
Vasomedical (Westbury, New York) said a study published in the December issue of Cardiology showed evidence of clinical safety and effectiveness in using enhanced external counterpulsation (EECP) as a first-line treatment for patients suffering from angina refractory to medical therapy. The study compared two populations of patients from the International EECP Patient Registry maintained at the University of Pittsburgh Graduate School of Public Health (Pittsburgh, Pennsylvania). The primary group of patients had no previous invasive revascularizations but were considered suitable for coronary artery bypass graft surgery or angioplasty. Results after a course of EECP therapy in this patient group were compared with refractory angina patients not suitable for further invasive procedures. The results showed both groups benefited from EECP immediately following the therapy, with about 75% of the patients improving their angina status, with reduced angina episodes and lowered use of nitroglycerin. The patients that were still candidates for invasive procedures were found to be substantially more likely to maintain or further improve their angina status six months following the treatment with significantly fewer hospitalizations and heart attacks. Vasomedical said that these results suggest EECP should be considered as a primary revascularization intervention after medical therapy proves to be unsuccessful.
Ventracor (Sydney, Australia) reported the fourth implant of its VentrAssist left ventricular assist system (LVAS) being billed as "Australia's artificial heart" at The Alfred Hospital (Melbourne, Australia). Professor Don Esmore, chief medical investigator for the pilot clinical trial, said the surgery went well and the patient was making a rapid recovery. He added that the patient's condition was stable and the VentrAssist was performing well. This is the latest implant of a series of up to 10 implants of the VentrAssist LVAS trial to evaluate the safety of the device.
Welch Allyn (Skaneateles Falls, New York) introduced two new multi-channel electrocardiographs (ECG), the Welch Allyn CP 10 and CP 20. Both units are battery operated and feature alphanumeric keyboards for easy entry of patient demographics, full-size user programmable reports that print on thermal paper, and advanced filters for optimal ECG trace quality. The more sophisticated CP 20 offers the option of connecting with many electronic medical record systems through the Welch Allyn CardioPerfect Workstation software. The Welch Allyn CP 10 offers non-interpretive 12-lead resting ECG with ECG measurements standard and an LCD screen for easy patient data entry. The Welch Allyn CP 20 offers the same easy-to-use operation and functionality as the CP 10, but also features an eight-channel ECG preview screen, and storage and transmission capability for up to 50 ECGs.
WorldHeart (Ottawa, Ontario) reported that the FDA has approved its premarket approval supplement submission to incorporate several engineering enhancements to the implanted and external components of its Novacor left ventricular assist system (LVAS). Improvements that will benefit recipients include: quieter pump operation; new battery packs that are 40% lighter and operate 40% longer; and a smaller and quieter battery charger. The implantable components of the system carry a three-year warranty, which remains unchanged. The company said introduction of the enhancements in the U.S. and Canadian markets will begin following completion of the final labeling and production of the modified systems. WorldHeart also reported that a heart failure patient in Germany became the 1,500th recipient of a Novacor LVAS. O.A. Dr. Latif Arusoglu, of the Department for Thorax and Heart Surgery at the Heart and Diabetes Center (Bad Oeynhausen, Germany), carried out the implant. The company said that the Novacor LVAS has "an industry-leading record for reliability and durability, and statistics unmatched by any other implanted electromechanical cardiac assist device on the market."
Xtrak Medical (Salem, New Hampshire) reported FDA clearance for its TOPS support catheter. The TOPS operates over standard .014" to .018" steerable guidewires to assist crossing difficult occlusions. Once the occlusion is crossed, TOPS is withdrawn while maintaining guidewire position and an angioplasty balloon is delivered through the pilot lumen that was formed across the occlusion. Since TOPS operates over standard guidewires, in either fully over-the-wire or rapid exchange versions, it can be easily incorporated into an ongoing procedure at any time without needing an exchange-length guidewire.