ImThera Medical Inc. said its tongue stimulation device for sleep apnea can improve patients’ snooze time.
The San Diego-based device maker concluded a European pilot study of its aura6000, an implanted neurostimulation device for treating obstructive sleep apnea (OSA) that delivers electrical pulses to the tongue during sleep.
The therapy uses a multi-contact electrode and programmable pulse generator, and provides treatment by producing muscle tone in certain tongue muscles to help control upper airway flow and reduce or eliminate sleep apnea, according to the company’s website.
The trial took patients who had varying levels of failure undergoing continuous positive airway pressure (CPAP) therapy for their OSA and gave them daily treatments with the aura6000. The company estimates that 38 million Americans have OSA and only 20 percent receive treatment for the condition, which involves pauses in breathing during sleep because of a narrowed or closed airway.
"We are very happy with the results of our pilot study showing significant improvements of OSA patients when using our aura6000 system. Especially with the very positive comments received from our patients," ImThera CEO Marcelo Lima said in prepared remarks.
The company is preparing for an investigational device exemption (IDE) application with the FDA as well as U.S. clinical trials, he said.
ImThera recently raised $1.8 million in a Series B funding round, according to a regulatory filing.
The company is planning to present the results from the study at the American Thoracic Society conference in Denver on May 16.
Here’s a roundup of recent clinical trial and scientific study news:
- For CREST study, higher initial risk with stenting for women
Women who undergo carotid artery stenting may have a higher risk during the procedure than those who have carotid endarterectomy, new study published online May 9 in Lancet Neurology shows, according to HeartWire. The research also indicates that there is little difference between these strategies for men. Results of a prespecified secondary analysis of women in the "Carotid Revascularization Endarterectomy versus Stenting Trial" (CREST) raise the question of whether sex of the patient should be taken into account when deciding between stenting and surgery to address carotid stenosis, writes the publication.
- Calypso touts studies on prostate cancer treatment system
Calypso Medical Technologies Inc. announced the results of two clinical studies demonstrating that real-time tumor tracking with its Calypso System during five-day stereotactic body radiotherapy (SBRT) for prostate cancer enabled clinicians to reduce treatment margins and minimize dosimetric impact of prostate motion. Data from one of the studies was presented at the 30th Anniversary Congress of the European Society for Therapeutic Radiology and Oncology (ESTRO) in London.
- Medtronic to present clinical data on interventional devices at EuroPCR
New clinical data on medical devices from Medtronic Inc. (NYSE:MDT), to treat cardiac and vascular diseases – from severe aortic stenosis and uncontrolled hypertension, to coronary and peripheral artery disease – will be presented next week at EuroPCR. Many of the presentations will be featured during late-breaking sessions at this large international interventional cardiology meeting, which takes place in Paris from May 17 – 20.
- Micell to present preclinical data for MiStent drug-eluting stent at EuroPCR
Micell Technologies Inc. announced that positive preclinical data will be presented at the EuroPCR conference in Paris, France on May 18 in a presentation titled, "MiStent DES: A Novel Third Generation DES with a Fully-absorbable Coating and Enhanced Drug Delivery Capabilities." The MiStent Drug-Eluting Coronary Stent System is an ultra-thin, advanced alloy drug-eluting stent distinguished by a rapid-absorbing drug/polymer coating formulation.
- Cook Medical touts study on esophageal lesion treatment
An technique for removing lesions associated with Barrett’s esophagus has been deemed a safe and effective treatment option in a study of more than 1,000 resections published this month in the European journal Endoscopy. The five-year study performed by a team of experienced endoscopists, is the largest prospective series to date to examine the safety and efficacy of multiband mucosectomy (MBM), an endoscopic procedure that is a simple and fast treatment option for Barrett’s esophagus, a condition that can result from gastroesophageal reflux disease (GERD).
- Covidien closes enrollment in Parietex ProGrip hernia repair study
Covidien (NYSE:COV) announced that all 600 patients have been enrolled in its clinical study comparing use of Parietex ProGrip self-fixating mesh to the gold-standard suture-based Lichtenstein repair method for primary inguinal hernias. Parietex ProGrip self-fixating mesh has resorbable polylactic acid microgrips that enable surgeons to position and securely place the mesh without the need for sutures.
- Abiomed touts latest PROTECT II data at SCAI conference
Abiomed Inc. (NSDQ:ABMD) announced results from further 90 day clinical and economic analyses, based on data from the PROTECT II study. The analyses showed a significant reduction of 29 percent in the Major Adverse Cardiac and Cerebrovascular Event (MACCE¹) rate for the Impella arm at 90 days. Additionally, the Impella patient population had overall average hospital charge savings of $19,000 (all patients) to $22,000 (survivors only) without device costs included. With the device costs included, hospital charges with Impella ranged from being equivalent to $3,000 less than the intra-aortic balloon pump (IABP).
- Endosense presents positive data at Heart Rhythm 2011
Endosense is touting a new study data supporting its TactiCath ablation catheter. Presented in six separate abstracts at last week’s Heart Rhythm 2011 in San Francisco, the data included findings from the company’s EFFICAS I post-market clinical trial that shed fundamentally new insights into the relationship between catheter tip-to-tissue contact force and early pulmonary vein isolation (PVI) line reconduction.
- GE Healthcare demonstrates interoperability at IHE Europe 2011
GE Healthcare IT announces the successful completion of interoperability testing at the Integrating the Healthcare Enterprise (IHE) Europe 2011 Connectathon in Pisa, Italy. During the weeklong event, April 11 – 15, GE Healthcare demonstrated the interoperability of its standards-based eHealth and imaging solutions with more than 130 healthcare IT systems from industry vendors.
- ArtVentive touts data on EOS device
ArtVentive Medical Group Inc. (OTC:AVTD) announced that the Company performed regulatory animal studies treating target vessels with its occlusion system – (EOS) device. The procedures had a 100 percent success rate in terms of safety and effectiveness.
- CardioFocus touts studies on HeartLight ablation system
CardioFocus, Inc., developer of the HeartLight Endoscopic Ablation System for the transcatheter treatment of Atrial Fibrillation (AF), announced its technology enables a Pulmonary Vein (PV) acute isolation rate of nearly 99 percent, with approximately 86 percent of PVs remaining persistently isolated after three months. Additional research also suggests that 65 percent of patients achieve durable freedom from AF after a single procedure.