Abbott touts 1-year real-world results from Amplatzer Amulet LAA study
Abbott (NYSE:ABT) today released real-world results from a study exploring the use of its Amplatzer Amulet left atrial appendage occlusion device in treating patients with atrial fibrillation.
Results from the study, which followed patients through to one year, showed that the device was able to help reduce stroke risk by 57% as compared to patient’s predicted stroke risk.
“Managing atrial fibrillation in patients who are at high risk of bleeding with blood thinning medicines is complex, and physicians must carefully weigh a patient’s risk for life-threatening bleeds versus stroke. These real-world prospective data provide important information on the clinical use and safety of left atrial appendage occlusion with the Amplatzer Amulet device, and demonstrate excellent occlusion of the left atrial appendage over time,” Dr. Ulf Landmesser of Berlin, Germany’s Charité Universitätsmedizin said in a press release.
The Amplatzer Amulet occluder is a second-gen version of the company’s LAA occlusion device and is designed to improve placement stability. Abbott claims that improvements to the device have resulted in shorter procedure times and more complete sealing or closure of the LAA.
“The results of our observational post-market study provide important information about the efficacy and safety of the Amplatzer Amulet device for stroke prevention in atrial fibrillation patients in a real-world setting. These findings support LAA occlusion as the preferred method for the prevention of stroke in people with atrial fibrillation,” Abbott structural heart biz VP Michael Dale said in a prepared statement.
Micell Tech releases 2-year Dessolve III MiStent trial data
Micell Technologies yesterday released two-year data from the Dessolve III trial of its MiStent sirolimus eluting absorbable polymer coronary stent system, touting a continued lower rate of clinically-driven target lesion revascularization and a lower rate of definite stent thrombosis.
In the trial, Durham, N.C.-based Micell compared the MiStent to Abbott’s Xience DES, and reported that the trial was unique in that the MiStent “maintained numerically lower point estimates versus Xience for any revascularization, target vessel revascularization and target vessel failure.
The company added that the trial wasn ot powered to show statistical significance between the MiStent and Xience.
“As we expected, there was no evidence of late catch-up in TLR in the MiStent group. Additionally, these Dessolve III data reinforce MiStent’s outstanding safety profile that we first noted in the Dessolve I and II trials, as evidenced by very low probable or definite stent thromboses. This ultra-thin strut stent should become an essential component to a best practices approach to coronary artery disease management, in which advances in both technology and technique are embraced. MiStent is an innovative tool that has the potential to improve long-term clinical outcomes,” Dr. William Wijns of The Lambe Institute for Translational Medicine at the National University of Ireland said in a press release.
“In the Dessolve III data, we are pleased to observe the same overall progression of TLR over time that was noted in earlier studies, despite the significant challenges represented by patients in the Dessolve III all-comers population. The clinical results we are seeing in these studies validate the hypotheses generated from Tzafriri et. al. recently published in the Journal of Controlled Release. This research found that crystalline sirolimus combined with MiStent’s proprietary coating technology could lead to optimized drug delivery and enhanced clinical results,” Micell chief medical advisor Dr. Dennis Donohoe said in a prepared statement.
CeloNova Biosciences touts low rates of stent thrombosis, TLR in Cobra PzF post-market study
CeloNova BioSciences yesterday released one year clinical trial results from a post-market study of its Cobra PzF nanocoated coronary stent system.
Data from the trial indicated a 4.3% rate of target lesion revascularization, 0.3% rate of late stent thrombosis and an 8.6% rate of major adverse cardiovascular events in patients labeled as high risk for bleeding and thrombosis, the San Antonio, Texas-based company said.
“The data from this trial provides further evidence that Cobra PzF NCS is a safe and effective treatment, particularly in complex patients with heart disease. Being able to provide an effective therapy that meets the needs of patients who are at higher risk of bleeding is of great clinical value,” principal investigator Dr. Luc Maillard of Aix-en-Provence, France’s Clinique Axium said in a press release.
“I am very excited by eCOBRA’s outstanding results as they support Cobra PzF NCS’ ability to offer an individualized treatment option for a greatly underserved population of high-risk patients. We look forward to further exploring its safety and efficacy in our first-of-its-kind Cobra Reduce trial with ultra-short, 14-day DAPT,” CEO Jason Cone said in a prepared statement.
Report: Mitral Valve Technology trials picking up steam
Trials exploring new technologies for treating mitral regurgitation are quickly advancing, according to a new report from TCTMD.
Enrollment in sessions related to the mitral valve replacement are picking up, and investigators are now able to delve into more complicated clinical issues and explore the use of mitral valve technology amongst more diverse patient populations, according to the report.