CD&Ds

The FDA said last month that Johnson & Johnson (New Brunswick, New Jersey) won agency approval for two devices to treat atrial fibrillation (AF).

The NaviStar ThermoCool and the EZ Steer ThermoCool Nav, produced by J&J's Biosense Webster (Diamond Bar, California) unit, are the first ablation catheters approved to treat AF, the agency said in a statement.

The FDA has granted marketing approval to the NaviStar ThermoCool Catheter for the treatment of drug-refractive recurrent symptomatic paroxysmal AF, when used with compatible three-dimensional electroanatomic mapping systems.

The ThermoCool is a saline irrigated radio frequency ablation catheter that can be used to create small, strategically placed scars in heart tissue to block irregular electrical waves that cause atrial fibrillation. The FDA previously approved other ablation catheters to treat arrhythmias such as atrial flutter and ventricular tachyarrhythmia, but not AF.

"[This] announcement is a milestone for electrophysiologists, physicians who specialize in heart rhythm disorders, and their patients throughout the U.S.," said Marcia Yaross, PhD, VP, clinical, regulatory and health policy at Biosense Webster. "This landmark decision by the FDA recognizes the safety and effectiveness of NaviStar ThermoCool Catheter ablation for the treatment of paroxysmal AFib and gives the medical community another treatment option for many patients whose often debilitating symptoms are not effectively managed through medical therapy."

"This approval provides physicians with another option for treating this common and potentially debilitating condition," said Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health.

As a condition of approval, BioSense Webster must establish a physician training program and conduct postmarket studies to collect data on these devices' long-term safety and effectiveness (including incidence of stroke, mortality, cardiac arrest, major bleeding, and pulmonary vein stenosis), and the effect of physicians' experience in operating the device on procedural safety.

FDA noted that AF is usually treated with drugs, and in certain severe cases, with open heart surgery. Catheter ablation should be used only after drug treatment has failed to adequately control the symptoms of the condition.

The FDA based this approval on a clinical study of 167 patients at 19 medical centers in the U.S., Brazil, Canada, the Czech Republic, and Italy. Data from the study showed the devices to be effective in eliminating symptomatic recurrence of AF episodes for one year in about 63% of treated patients vs. 17% of the patients in the control group.

The catheters were the focus of an FDA Circulatory System Devices advisory panel last November, when they received the panel's unanimous recommendation for approval.

Elsewhere in the product pipeline:

• Boston Scientific (Natick, Massachusetts) said that it has submitted to FDA the final modules of the company's PMA applications for both its Taxus Liberté Atom paclitaxel-eluting coronary stent system and its Taxus Liberté Long paclitaxel-eluting coronary stent system. If approved, the Liberté Atom stent will become the company's second 2.25 mm diameter drug-eluting stent (DES) available in the U.S. Boston Scientific says that it will then likely succeed the Taxus Express Atom stent, the company's first approved small stent and the only DES currently approved by the FDA to treat small vessels. The Taxus Liberté Long stent is designed to be the first 38 mm drug-eluting stent available in the U.S. and will further expand the company's DES portfolio.

• CryoLife (Kennesaw, Georgia) said the FDA has cleared a new claim for the CryoValve SG pulmonary human heart valve. The new labeling claim relates to reducing a component of the immune response in recipients of the CryoValve SG. CryoValve SG pulmonary human heart valve is processed with the company's SynerGraft technology, which is designed to remove allogeneic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen matrix. The new claim relates to the fact that data from three company-sponsored clinical studies and a comprehensive review of the scientific literature on allograft heart valves shows that implantation of the CryoValve SG reduces the risk of inducing HLA class I and class II alloantibodies, based on Panel Reactive Antibody measured at up to one year, compared to the standard processed pulmonary human heart valve. The CryoValve SG pulmonary human heart valve is indicated for the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary valves. The valve can be used in conjunction with right ventricular outflow tract reconstruction procedures, commonly performed in children with congenital heart defects.

• Diagnosoft (Morrisville, North Carolina) reported its newest software solution, Diagnosoft SENC. Strain-encoding, or SENC, is a new MRI analysis technique that will help physicians measure regional contraction, or relaxation, of the heart's myocardium. Diagnosoft SENC enables quantification of data to improve diagnosis and guide monitoring and treatment of coronary artery disease. Nael Osman, co-founder of Diagnosoft, said, "Diagnosoft SENC provides an objective way to assess regional variations in muscle contraction due to ischemia, myocardial infarction, or other causes. Moreover, Diagnosoft SENC produces maps of regional function with high spatial resolution at a level of quality sufficient even for the thin wall of the right ventricle. As a result, the technique can reveal small regional anomalies in contractility within the wall." Most cardiac MRI procedures require patients to hold their breath. However, SENC images can be acquired in a fraction of a second, mapping regional function with unprecedented speed, so it can be used in combination with tests and maneuvers that allow patients to breathe normally. That means SENC is suitable for stress testing of cardiac function, as well as other diagnostic tests.

• Evalve (Menlo Park, California) reported the start of enrollment in the REALISM (Real World ExpAnded MuLtIcenter Study of the MitraClip System) study, a continued access registry. The MitraClip system is currently being evaluated in the U.S. as a non-surgical treatment option for patients suffering from the effects of mitral regurgitation (MR). Percutaneous mitral repair with Evalve's MitraClip system is performed by physicians in the catheterization laboratory. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. In addition to improving blood flow through the heart, the procedure may also relieve symptoms such as fatigue and shortness of breath that often affect patients with significant MR. After treatment, patients generally recover quickly. The MitraClip therapy may improve quality of life and may help MR patients avoid or delay surgery, having preserved surgical options (valve repair or replacement) should surgery become necessary.

• iTMP Technology (Santa Barbara, California), an iPhone hardware and software developer, reported the commercial launch of SMHEART LINK, a new technology that allows an Apple iPhone or iPod to double as a heart monitor and fitness tracking system that actually listens to a person's heart. In addition to the iPhone and iPod touch, SMHEART LINK can be compatible with other smartphones, PCs or other Wi-Fi enabled devices. SMHEART LINK is a wireless bridge that collects data from distributed health and fitness sensors such as heart rate monitors and cycling sensors and sends it to the iPhone via Wi-Fi. iTMP's suite of iPhone fitness apps allow users to track their fitness data on iPhone's display. It also is compatible with biking sensors to track speed, cadence and power (watts).

• Medtronic (Minneapolis) reported the completion of enrollment in PROTECT, the company's global study comparing its Endeavor drug-eluting stent (DES) to Johnson & Johnson's Cypher DES. PROTECT is powered to detect a clinically significant difference in rates of stent thrombosis between the two devices. Stent thrombosis is a rare but serious adverse event in which a blood clot forms inside the stent, with the potential to cause heart attack or death. Occurrences after one year post-implant are called very late stent thrombosis (VLST) and a subject of significant concern. VLST emerged as a safety concern with the first generation of DES in 2006, when clinical trials conducted to support the regulatory approvals of these devices revealed a numerical increase in the rate of VLST compared to BMS controls. PROTECT's primary endpoint is overall stent thrombosis at three years; secondary endpoints include death and non-fatal myocardial infarction, target lesion revascularization and target vessel revascularization.

• Osiris Therapeutics (Columbia, Maryland) reported the final two-year results for the company's trial evaluating Prochymal for the treatment of acute myocardial infarction. Prochymal is a formulation of adult stem cells designed to provide therapeutic benefit by controlling inflammation, promoting tissue regeneration, and preventing scar formation. This study, which evaluated safety and preliminary efficacy, found that heart attack patients receiving the intravenous therapy had lower rates of adverse events and significantly improved heart function. Prochymal is a preparation of mesenchymal stem cells specially formulated for intravenous infusion. The stem cells are obtained from the bone marrow of healthy adult donors. Prochymal is currently being evaluated in Phase III trials for steroid refractory GvHD, acute GvHD, and Crohn's disease.

• Pathway Medical Technologies (Kirkland, Washington) has received FDA clearance to market its newest peripheral atherectomy catheter for use in the treatment of peripheral artery disease (PAD) in the lower limbs. Jetstream G2 is the latest technology innovation from Pathway and the company says it is capable of treating the entire spectrum of disease found in the PAD patient, including hard and soft plaque, calcium, thrombus and fibrotic lesions, with consistent results. Jetstream is a peripheral atherectomy catheter designed to remove all kinds of artery-clogging plaque in the lower limbs of patients. This innovative and minimally invasive solution clears blockages in the peripheral vasculature, restores blood flow and effectively treats PAD. The Jetstream consists of a sterile, single-use catheter and control pod and a reusable, compact console that mounts to a standard IV stand. The catheter has an expandable cutting tip that safely debulks and preemptively removes both hard and soft plaque, as well as calcium, thrombus and fibrotic lesions. Excised tissue and thrombus are continually aspirated from the peripheral treatment site through a port system to a collection bag located on the console. The distal portion of the catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure.

• Sensiotec (Atlanta) reported FDA 510(k) Class II clearance for the ultra-wideband (UWB) non-contact, continuous monitor for heart and respiration rates, bed occupancy and movement. Under the brand name Preventa, Sensiotec will market and sell the device in the U.S and Canada under an exclusive worldwide license with its affiliate, Wireless 2000 (Burnaby, British Columbia). Preventa harnesses the potential of UWB, an emerging wireless communications standard and former classified military technology, creating a wireless vital signs monitor.

• St. Jude Medical (St. Paul, Minnesota) reported that the FDA approved what is being called the first medical device system that allows a single defibrillation lead connection between a cardiac resynchronization therapy defibrillator (CRT-D) and the leads that send electrical impulses to the heart to treat the symptoms of heart failure. The new connector system, which includes the Durata defibrillation lead with the SJ4 connector and the Promote CRT-D with the SJ4 connector, is expected to make the overall procedure a simpler process. In addition, the new system reduces the volume of the leads and device in the chest pocket, which could lessen the risk of lead-to-can abrasion, a known complication. The SJ4 connector system features a single connection between the CRT-D and the defibrillation lead and a single set screw. Current lead designs require three separate connections and four set screws. The St. Jude Medical SJ4 connector system was designed to meet the draft International Organization of Standardization IS-4 standard but will not be labeled as such until the standard is published, which is expected later this year. As a requirement of the FDA approval, St. Jude Medical will conduct a post-approval study that will enroll up to 1,700 patients and follow the group for five years.

• W. L. Gore & Associates (Flagstaff, Arizona) received FDA approval last month for a device that reverses the flow of blood during carotid artery stenting procedures, offering a level of protection unavailable before. The Gore Flow Reversal System is neuroprotection technology that literally reverses the flow of blood at the treatment site prior to crossing the lesion so there's almost no chance that particles could escape to the brain. "The current standard relies on continuous normal blood flow where debris that's released from the lesion is captured upstream or closer to the brain in a mechanical filter," said Stuart Broyles, PhD, Stroke Interventions Business Unit leader at Gore. "In our case, we're flushing blood in the opposite direction of normal flow passed the lesion to flow down the balloon sheath to be filtered outside the body." Flow reversal is achieved by selectively blocking the common carotid and external carotid artery blood flow.