The launch of a pivotal clinical trial next year for a “hybrid” procedure to treat atrial fibrillation patients will be an “inflection point” for cardiac surgical device maker AtriCure Inc.’s (NSDQ:ATRC) U.S. business, the company’s CEO said.
The pivotal clinical trial, which could lead to regulatory approval of the hybrid procedure to treat atrial fibrillation and is called DEEP AF, will involve expanding studies from six research centers to 35, CEO David Drachman said.
The West Chester, Ohio-based company is in talks with a number of clinical centers regarding participation in the trial.
The hybrid procedure, which combines AtriCure’s minimally invasive surgical ablation devices with a catheter-based ablation system from BioSense Webster, holds a U.S. market potential of $2 billion, Drachman has previously said. A feasibility trial of the hybrid procedure enrolled its first patient late last year.
Drachman spoke with analysts in a conference call discussing AtriCure’s first-quarter financial results. The company’s quarterly loss narrowed to $1.3 million from $2 million in the year-earlier quarter. Last quarter, AtriCure reported its first-ever profitable quarter.
First-quarter revenue grew 12 percent to $15.6 million, highlighted by 21 percent growth in international sales. The company reported sales of $1.5 million of its AtriClip device, a clip used during heart surgery to exclude the left atrial appendage. This exclusion helps protect atrial fibrillation patients from strokes. That was up from $1.3 million last quarter.
Drachman said the company plans to use the AtriClip device, which sells for an average of about $1,100, to “open new doors” and “pull through” sales of new ablation technologies the company is planning to launch. About 100 of the company’s top 250 accounts are stocking the device.
Here’s a roundup of recent clinical trial and scientific study news:
- Journal of American College of Cardiology publishes study on robot-assisted angioplasty
Natick, Mass.-based Corindus Vascular Robotics, a developer of precision vascular robotics, announced that the Journal of American College of Cardiology: Cardiovascular Interventions published the results from the first-in-human clinical study of its CorPath 200 System in the April 2011 issue (2011;4:460–465). The study was designed as a single-arm, open label, prospective trial to evaluate the safety and technical efficacy of the CorPath 200 System in delivering and manipulating coronary guidewires and stent/balloon systems in percutaneous coronary intervention (PCI) procedures.
Read more - HeartMate II LVAD gets positive marks in patient trial
Patients implanted with a HeartMate II (Thoratec) left ventricular assist device (LVAD) following its 2008 FDA approval have had similar outcomes to what was predicted by the clinical-trial results. A comparison of the outcomes of the HeartMate II with similar patients treated with other LVADs shows that "dissemination of this technology after approval has been associated with continued excellent results," according to study authors Dr Randall Starling (Cleveland Clinic, OH) and colleagues, writes HeartWire.
Read more - Cardiac Dimensions initiates two clinical studies on its mitral contour device
Cardiac Dimensions Inc. announced the initiation of two new clinical studies using the CARILLON Mitral Contour System, an investigational device for percutaneous treatment of Functional Mitral Regurgitation. The CARILLON system is a minimally invasive device designed to repair the heart’s mitral valve and reduce FMR, a disorder that affects most of the estimated 5 million people in the U.S. and more than 20 million people worldwide suffering from heart failure.
Read more - Lantheus touts safety studies on DEFINITY to FDA dvisory committees
Lantheus Medical Imaging completed a meeting with the FDA Cardiovascular and Renal Drugs Advisory Committee and Risk Management Advisory Committee, which convened on May 2 to review safety data of ultrasound contrast agents from three manufacturers. The meeting was intended to provide an interim update on post-marketing safety studies and pharmacovigilance activities since the last advisory committee meeting in 2008. Lantheus Medical Imaging presented safety data for DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension.
Read more - Second Sight touts Argus II retinal prosthesis trial
Second Sight Medical Products Inc.’s Argus II Retinal Prosthesis System clinical trial included 30 subjects implanted in 10 centers worldwide, and has run for nearly 4 years. The results that were presented from the trial showed that the Argus II System provided significant improvements in vision for the blind subjects who are suffering from profound Retinitis Pigmentosa.
Read more - Neoprobe reports positive results from Lymphoseek trial
A phase 3 clinical trial showed Neoprobe‘s (NYSE Amex:NEOP) radiopharmaceutical Lymphoseek to be superior to the current standard of care in identifying cancerous lymph nodes in patients with breast cancer or melanoma. With the positive results of the trial in hand, Neoprobe CEO Mark Pykett reiterated the Dublin, Ohio’s company’s plans to file for regulatory approval of the drug in the third quarter, according to a statement from Neoprobe, writes MedCity News.
Read more - BioTime begins clinical development on HyStem-Rx as a cell delivery device
BioTime Inc. (NYSE Amex:BTX) announced that it has elected to seek regulatory approval of HyStem-Rx as an implantable cell delivery vehicle that can be used to significantly improve outcomes in reconstructive surgery and potentially a wide array of other cell-based therapies.
Read more - pSivida touts study of ILUVIEN in macular edema
pSivida Corp. (NSDQ:PSDV) presented new data from the completed 36-month FAME Study of ILUVIEN for the treatment of Diabetic Macular Edema (DME) at the 2011 ARVO Annual Meeting. The new data, presented by Dr. Andrew N. Antoszyk, analyzed the subgroup of patients who had been diagnosed with DME for three or more years at entry of the FAME Study (which comprises over 50% of patients in the Study).
Read more - EBR Systems reports first human implants of wireless cardiac stimulation device
EBR Systems Inc., a privately held clinical stage company, announced the first human implants of the WiCS Wireless Cardiac Stimulation System. The WiCS cardiac pacing system represents a significant medical breakthrough, eliminating the cardiac pacing lead by stimulating the heart through wireless transmission of energy.
Read more - Cyberonics reports first implant of AspireSR seizure response device
Cyberonics Inc. (NSDQ:CYBX), a global leader in epilepsy management, announced the first implant of its AspireSR seizure response product on April 27, 2011. The implant, conducted under the care of Professors Paul Boon and Dirk Van Roost and their teams at the Ghent University Epilepsy Group in Ghent, Belgium, was received by a patient with ictal tachycardia (heart rate increases associated with seizures) who has been suffering with epilepsy for many years.
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