FDA Approvals: EndoSure AAA, Therapy Cool Path, AngioJet Spiroflex VG

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Yael Waknine

April 9, 2007 — The US Food and Drug Administration (FDA) has granted 510(k) clearance for a wireless pressure management system in thoracic aortic aneurysm repair as well as approvals for a radiofrequency ablation catheter in the treatment of atrial fibrillation and a rapid-exchange catheter in coronary thrombus removal.

Wireless Pressure Management System (EndoSure AAA) for Use in TAA Repair

On March 15, the FDA granted 510(k) clearance for a wireless pressure management system (EndoSure AAA; CardioMEMS, Inc), allowing its use for the measurement of intrasac pressure during thoracic aortic aneurysm (TAA) repair, a new indication.

The system consists of an implantable sensor with radiopaque markings that is placed in the TAA sac during stent graft deployment and left in the excluded portion of the aneurysm as a permanent implant. Real-time sensor information is obtained by placing the antenna of the external electronics module over the patient's abdomen; once the signal is acquired, a pressure waveform and numerical pressure data are displayed on the touch screen and a printout generated from the integrated thermal printer.

According to a company news release, microelectromechanical systems (MEMS) technology is used to produce the millimeter-scale sensor with internal features in the nanometer to micrometer range.

The device was previously approved for use in abdominal aortic aneurysm repair and as an adjunctive tool in the detection of intraoperative leaks.


RF Ablation Catheter (Therapy Cool Path) for the Treatment of Cardiac Arrhythmias

On March 16, the FDA approved an ablation catheter (Therapy Cool Path; Irvine Biomedical, Inc) for use with a compatible external infusion pump and the company's IBI 1500T9 radiofrequency (RF) generator at a maximum of 50 watts. The device creates endocardial lesions during cardiac ablation procedures (mapping, stimulation, and ablation) to treat cardiac arrhythmias such as supraventricular tachycardia and atrial flutter (AF).

According to company information, the 7-French catheter features open irrigational ducts at the distal tip to enable cooling of the 4-mm tip electrode via saline infusion, thereby allowing delivery of higher RF energy while minimizing the risk for coagulation and charring to create deeper lesions. The device is available in medium (3.2 cm), large (4.1 cm), and extra large (5.0 cm) diameters.

Its approval was based on data from a prospective, randomized, multicenter clinical study (n = 326) showing that device safety and efficacy were noninferior to a previously approved control device.

Results showed similar acute success rates between groups (92.53% vs 96.67%), defined as the creation of a bidirectional conduction block and noninducibility of AF using the catheter.

Of those who have undergone a successful procedure, 96.6% vs 97.5% of patients were free from arrhythmia recurrence during the ensuing 3-month period; 78.5% vs 85.2% also did not require adjustment of preablation antiarrhythmic therapy (new drug or increased dose).

No unanticipated serious device-related adverse events were reported in patients treated with the investigational or control device, and 7-day major adverse cardiac event rates were also comparable (6.90% vs 8.89%).


Rapid Exchange Catheter (AngioJet Spiroflex VG) for Coronary Thrombus Removal

On January 25, the FDA approved a new indication for a rapid exchange catheter (AngioJet Spiroflex VG; Possis Medical, Inc), allowing its use for thrombus removal in coronary arteries, including saphenous vein bypass grafts and larger native vessels.

According to company information, the catheter uses the same technology as the company's Spiroflex device, which is indicated for use in smaller coronary arteries and peripheral vessels. It offers twice the clot removal power compared with AngioJet 4F RX catheters (0.138 g/sec vs 0.61 g/sec; P = .00015) and is compatible with 7-French guides and 5-French sheaths, allowing effective targeting of 3- to 8-mm vessels with for 360° thrombus removal.

Additional features include increased flexibility of the spiral shaft at the distal end to accommodate tight bends and a distal hydrophilic coating to reduce friction. A long taper tip with a 25-cm guidewire lumen provides an improved crossing profile with minimal drag, and the soft tip material conforms and tracks through tight vessels.

The device was previously approved in the United States, the European Union, and other international markets for removing thrombus from larger peripheral arteries.

http://www.medscape.com/viewarticle/554899?src=mp