Nov. 4, 2024 — Royal Philips recently announced enrollment of the first patient in the U.S. THOR IDE clinical trial, which will study an innovative combined laser atherectomy and intravascular lithotripsy catheter that integrates two critical PAD treatments into a single device. Procedures that previously required the use of two different devices can now be performed in a single procedure using a single device, simplifying workflows and procedures and potentially reducing the risk and improving outcomes for patients who might otherwise face multiple complex interventions. 

Medtronic recently announced results from two studies evaluating the utility of atherectomy for peripheral endovascular interventions. Results from both analyses were released at the Vascular InterVentional Advances (VIVA) 2024 conference in Las Vegas.

Nov. 1, 2024 — Recor Medical, Inc. and its parent company, Otsuka Medical Devices Co. recently announced U.S. Centers for Medicare & Medicaid Services (CMS) have granted the company’s Paradise Ultrasound Renal Denervation system a Transitional Pass-through (TPT) payment. The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years.

Nov, 4, 2024 – R3 Vascular Inc. has announced that the U.S. Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval to initiate its ELITE-BTK pivotal trial of its next generation drug eluting bioresorbable scaffold, MAGNITUDE, for below-the-knee (BTK) PAD. 

Oct. 28, 2024 — Cardiawave SA, developer of Valvosoft Non-Invasive Ultrasound Therapy (NIUT) device for treating severe symptomatic calcific aortic stenosis (CAS),  announced that the device met the primary endpoint in its pivotal study and improved or stabilized heart failure symptoms for 80.5 percent of patients, substantially improving hemodynamics and patient quality of life six months after treatment.

Nov. 5, 2024 —Penumbra, Inc. recently announced new data that demonstrate patients with intermediate-risk pulmonary embolism (PE) treated with Penumbra’s computer assisted vacuum thrombectomy (CAVT) technology have a shorter length of hospital stay, shorter post-procedure length of stay and fewer complications compared to other treatment options. Additionally, in-hospital mortality was low with CAVT, with no significant difference between treatment options. The late-breaking study was presented this week at the Vascular Interventional Advances (VIVA) 2024 Conference.

Oct. 24, 2024 — Medtronic plc has announced United States Food and Drug Administration (FDA) approval of the Affera Mapping and Ablation System with Sphere-9 Catheter, an all-in-one, high-density (HD) mapping and pulsed field (PF) and radiofrequency (RF) ablation catheter for treatment of persistent atrial fibrillation (AFib) and for RF ablation of cavotricuspid isthmus (CTI) dependent atrial flutter.

Oct. 27, 2024 — HeartFlow, Inc.  recently announced seven-year data confirming the use of HeartFlow’s AI-enabled fractional flow reserve computed tomography (FFRCT) and Plaque Analysis in the assessment of long-term risk of coronary artery disease (CAD) in clinically stable, symptomatic patients. The data show the HeartFlow platform provides clinicians with the insights needed to anticipate and mitigate adverse events, including myocardial infarctions, in symptomatic patients with stable chest pain.

Oct. 30, 2024 — HeartLung Technologies, a developer of AI tools for early detection of heart disease, lung cancer and other conditions announced that its AI-enabled Automated Cardiac Chambers Volumetry (AutoChamber) recently received “Breakthrough Medical Device” designation and marketing authorization from the U.S. Food and Drug Administration.

Impella ECP pump insertion. 

 

Oct. 28, 2024  — Results from the first completed pivotal trial on patients supported with Impella ECP, a novel transvalvular axial flow pump with compressible pump architecture were presented at Transcatheter Cardiovascular Therapeutics (TCT) 2024 conference in Washington, D.C.

Impella ECP is a technology of Abiomed, part of Johnson & Johnson MedTech, and a global leader in heart recovery.

 

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