HomeCLINICAL TRIALS, STUDIES, REGISTRIES, DATA
CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Aquedeon Medical Announces First Patient Enrolled in the IDE Study of Duett Vascular Graft System
This February, the first enrolled patient underwent open surgical aortic arch reconstruction at the University of Pennsylvania, Presbyterian Medical Center, Philadelphia, PA. During the surgery, the Duett Vascular Graft System was successfully deployed to connect the native left common carotid artery to the surgical graft.
Auxilius Pharma Announces Top-line Results of its First-in-Human Clinical Study into the Pharmacokinetics, Safety and Tolerability of Antianginal AUX-001
AUX-001 is an innovative, once-daily, extended-release formulation of Nicorandil. For decades, immediate-release, twice daily Nicorandil has been a cornerstone treatment for chronic angina symptoms outside the US, distinguished by its dual mechanism of action that targets both the micro- and macrovascular coronary artery flow bed, and providing sustained angina symptom relief without the common issue of tachyphylaxis seen with other anti-anginal vasodilators like long-acting nitrates. AUX-001 offers efficacy comparable to conventional anti-anginal medications such as beta-blockers, calcium channel blockers, and long-acting nitrates while also potentially enhancing control of the underlying coronary disease and reducing angina related hospitalizations.
Conformal Medical’s CLAAS® System Demonstrates Low Thrombogenicity Compared to Commercially Available LAAO Devices
Conformal Medical is actively enrolling patients in the CONFORM pivotal trial, evaluating the safety and efficacy of the CLAAS System compared to other commercially available LAAO devices. The prospective, multicenter, randomized controlled study will enroll approximately 1,600 patients.
Bodyport Reports | Heart Failure Monitoring Technology Doubles Sensitivity for Predicting Events While Minimizing False Alerts Versus Standard of Care
“This should be welcome news for patient care teams because a greater prediction rate with fewer false alerts translates into more effective and efficient care,” said Corey Centen, founder, president, and chief technical officer at Bodyport. “What’s more, use of the Cardiac Scale and the Congestion Index is a seamless transition for clinicians and patients because it enhances, rather than replaces, the existing pathways built around weight monitoring. The lower alert rate should lead to workflow efficiencies because care teams—who are often feeling overly burdened by the large number of notifications and data flowing in—will spend less time responding to false alerts.”
Berlin Cures: BC 007 Targets Long COVID: Solid Phase II Trial Progress with Over 50% Patient Recruitment
The potential of BC 007 extends beyond treating a single disease, making it a so-called platform technology. By neutralizing fAABs, BC 007 could potentially act against many fAAB-associated diseases.
BD Initiates International Study to Expand Treatment Options for Patients with Peripheral Arterial Disease
Dr. Sean Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic and National Principal Investigator of the AGILITY Study said, "When we're addressing advanced peripheral arterial disease, a self-expanding covered stent can play an important role. We need a stent that can track to the lesion, apposes the vessel wall and ultimately provides long-term durability. We're excited to see how this technology performs."
Argonne Uncovers Insights About Prostate Cancer Risk and Genetic Ancestry
The project, which was led by the University of Southern California, included large increases in representation among men of African, Hispanic and Asian ancestries, that were contributed in part by an ongoing collaboration between the U.S. Department of Veterans Affairs and DOE reports Argonne.
UroMems Announces Results of 1s Ever Smart Artificial Urinary Sphincter Implant in Female Patient to Treat Stress Urinary Incontinence
The company reports they have successfully met the six-month primary endpoint for the first-ever female patient implanted with the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI.
AppliedVR and Kernel Flow Announce Clinical Results Evaluating How Brain Changes During Virtual Reality Treatment of Chronic Pain
AppliedVR Co-founder and President Josh Sackman, "We're committed to developing a significant body of scientific evidence that demonstrates how our RelieVRx program, which is rooted in self-regulation, cognitive behavioral therapy skills and mindfulness, engages the brain and can impact the experience of pain. While we know there can be a strong placebo effect, this feasibility study showed that only the active RelieVRx treatment created changes at a physiological and brain activity level, creating a strong foundation for future research."