News and Announcements
nContact Surgical, Inc.
12.01.2009
nContact Announces Initiation of Clinical Trial for the Treatment of Paroxysmal Atrial Fibrillation Utilizing New Convergent Ablation Procedure
nContact Surgical, Inc, a leader in the investigation of devices for minimally-invasive treatment for heart conditions, today announced the initiation of a feasibility clinical trial designed to evaluate the safety and efficacy of a combined surgical and catheter procedure, the convergent procedure, for the treatment of symptomatic paroxysmal atrial fibrillation (AF). This prospective, feasibility study will enroll patients at study sites across the United States. The study utilizes the nContact Numeris- AF Guided Coagulation System with VisiTrax® along with a commercially available ablation catheter, the Biosense Webster NaviStar® ThermoCool® Catheter. The combination of devices creates a standard, bi-atrial lesion pattern to block electrical signals that cause AF. In addition, electrophysiologists have the capability to diagnostically ensure the lesion pattern is complete with pulmonary vein isolation.
11.19.2009
nContact Results Presented at AHA: First Study Reviewing Convergent Approach to Treating AF Reveals 80% Success Rate
nContact Surgical, Inc, a leader in the investigation of devices for non-invasive treatment for heart conditions, yesterday announced that data from a poster was presented at the American Heart Association Scientific Sessions in Orlando, Florida. The study demonstrated that the convergent approach, which combines surgical and electrophysiological expertise, appears to be a good strategy to achieve short term success in patients with long standing persistent atrial fibrillation (AF).
“This study represents the first combined surgical and electrophysiological approach to treat the most challenging AF patients without any chest incisions or ports,” said Dr. Rodney Horton, Electrophysiologist at St. David’s Medical Center in Austin, Texas. “We are pleased with the results from these initial convergent experiences. All patients left the procedure room in normal sinus rhythm with confirmed pulmonary vein isolation. Additionally, 80 percent of patients remained in normal sinus rhythm and off anti-arrhythmic drugs at six months.”
11.16.2009
nContact Announces Initiation of Clinical Trial for the Treatment of Atrial Fibrillation in Open-Chest Procedures
nContact Surgical, Inc, a leader in the investigation of devices for non-invasive treatment for heart conditions, today announced the initiation of a clinical trial designed to evaluate the safety and efficacy of its Numeris® – AF Tethered Coagulation System with VisiTrax® device in an open-chest concomitant procedure for the treatment of longstanding persistent atrial fibrillation (AF). This multi-center, non-randomized, prospective clinical trial will enroll up to 107 participants at 15 study sites across the United States.
Cayenne Medical, Inc.
04.08.2010
Cayenne Medical AperFix System Shows Successful Outcomes For PCL Reconstruction
A a new independent clinical study published in the February 2010 issue of Orthopedics reports Cayenne Medical’s AperFix® System provides a safe, efficient and secure means of arthroscopic reconstruction of the posterior cruciate ligament (PCL) due to traumatic injury.
03.04.2009
Independent Harvard Study Favors Aperfix
American Journal of Sports Medicine
A new Harvard clinical study published in the American Journal of Sports Medicine (AJSM) found that Cayenne Medical’s AperFix System and “Single Tunnel, Double Bundle” ACL reconstruction technique better resembles the natural, intact ACL when compared to the more common, “Single-Bundle” technique.
03.2009
Aperfix System Granted Expanded Indications
Cayenne Medical, Inc. announced that their AperFix Femoral and Tibial Implants received 510K clearance from the U.S. Food and Drug Administration (F.D.A.) for extended indications for use. This means that the truly versatile AperFix System is not only a superior solution for ACL reconstruction, but is now indicated for a wide variety of tenodesis procedures such as PCL, MCL, LCL and MPFL reconstruction.