Penumbra Inc.’s 'resoundingly positive' results from its STORM-PE trial could see current guidelines for anticoagulant use in pulmonary embolism swept away in favor of mechanical thrombectomy. A deluge of favorable comments by experts and analysts followed the presentation during a late-breaking session at Transcatheter Cardiovascular Therapeutics, the annual scientific symposium of the Cardiovascular Research Foundation, which showed more than 50% improvement in treatment effect from Penumbra’s computer-assisted vacuum thrombectomy system plus anticoagulation compared to anticoagulation alone within two days with no increase in major adverse events.

Angiodynamics Inc. received CE mark approval for its Auryon atherectomy system which treats peripheral artery disease, including critical limb ischemia and in-stent restenosis. The regulatory clearance expands the company’s global reach as it sees increasing revenues from sales of the device.

In what represents the first patenting to emerge from Endeavor Med Inc., its founder and chief executive officer, Imran Faruqi, describes their development of a novel device capable of providing non-invasive cardiac pacing, defibrillation, and cardioversion, and which uses pacing currents at less than half that required by traditional chest pads.

In 2023, med-tech deals culminated in the highest total deal value ever recorded by BioWorld MedTech, totaling $10.63 billion, a 33% increase from the $7.99 billion recorded in 2022.

Angiodynamics Inc. said it has settled with the parent company of C.R. Bard Inc., over a series of conflicts over patents held by Bard that will cost Angiodynamics nearly $10 million just in 2024, potentially significantly more.

Lush vegetation is great for a gardener, but alarming for a cardiologist. For them, the news that Angiodynamics Inc. received U.S. FDA breakthrough device designation for its Angiovac system to remove vegetation from the right heart is surely cheering. Right heart vegetations--masses of fibrin, platelets and infectious pathogens--are indications of serious infective endocarditis.

Merit Medical Systems Inc. is making progress on its acquisition badge, with a $100 million purchase of assets from Angiodynamics Inc. following shortly on the heels of its acquisition of a catheter system from Bluegrass Vascular Technologies Inc. for $32.5 million. The acquisitions strengthen Merit’s position in the specialty dialysis devices market and are expected to boost the company’s revenues $13 million to $15 million through Dec. 31, 2023, and by $30 million on an annualized basis going forward.

The FDA gave the greenlight to Route 92 Medical Inc. for its Freeclimb 70 reperfusion system in the treatment of ischemic stroke. The 510(k) clearance includes a Freeclimb 70 aspiration catheter, as well as a Tenzing 7 delivery catheter.

The Medicare inpatient draft is always an event due to its impact on medical technology. Now, several products soon may see their new technology add-on payments (NTAP) expire because of eligibility. The Centers for Medicare and Medicaid Services (CMS) said both Claret Medical Inc.’s Sentinel embolic protection device and Procept Biorobotics Corp.’s Aquabeam device have used up their NTAP eligibility, and hospitals may see lower rates for using those devices starting Oct. 1