Atheart Medical Inc. came on the market with splash, simultaneously announcing the company’s formation and its launch of a U.S. investigational device exemption (IDE) trial for the Resept ASD occluder, a device designed to close atrial septal defects. Resept features a metal-free, bioresorbable frame to reduce the risks associated with the long-term presence of metal in the heart.
Keeping you up to date on recent developments in cardiology, including: PCI still the treatment of choice for COVID-positive STEMI patients; Utility of risk scores for TAVR patients questioned; Plaque similarly predictive in women and men.
The FDA granted an investigational device exemption (IDE) to Hancock Jaffe Laboratories Inc. for Venovalve, clearing the way for the company to begin a pivotal trial of the implantable valve in patients with chronic venous insufficiency (CVI) of the deep veins of the leg. The company’s first patent covering the device was issued by the U.S. Patent and Trademark Office on April 7.
Endologix LLC said Tuesday that it has completed the acquisition of Pq Bypass Inc., a privately held company developing a novel technology for treating severe peripheral artery disease (PAD). Pq Bypass’ Detour system is currently being studied in a U.S. and European clinical trial, DETOUR2.
Plx Pharma Inc. is not letting out the details just yet about next quarter’s launch of liquid-filled aspirin capsule Vazalore, recently cleared by the FDA in 81-mg and 325-mg doses, but CEO Natasha Giordano said cardiologists are “essential to our strategy. We have developed very deep sales plans [that are] laser-focused.”
Keeping you up to date on recent developments in cardiology, including: Rheumatic aortic stenosis responds well to TAVR vs. SAVR; Cardiac MR may improve correct diagnosis of left ventricular non-compaction; Better management needed for infarct patients with mechanical complications.
Xenter Inc. has officially launched, positioning itself as the first startup device/data/drug med-tech company. The company is developing wireless solutions for interventional cardiology, interventional radiology and neurointerventional radiology.
Xenter Inc. has officially launched, positioning itself as the first startup device/data/drug med-tech company. The company is developing wireless solutions for interventional cardiology, interventional radiology and neurointerventional radiology. The company’s goal is to take the medical devices that have been used most ubiquitously throughout medicine, one by one, and replace them with smart technologies that incorporate such things as software, sensors and signals technologies.
Mineralys Therapeutics Inc., a Philadelphia-based company developing an aldosterone synthase inhibitor in-licensed from Mitsubishi Tanabe Pharma Corp. (MTPC), has raised $40 million in series A funding to complete a phase II proof-of-concept study in hypertension for the candidate, known as MLS-101.
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