April’s top 10 most popular stories include US Food and Drug Administration (FDA) approval of a frozen elephant trunk (FET) device, as well as new data presented at the American College of Cardiology’s annual scientific sessions (ACC.22, 2–4 April, Washington DC, USA).
1. Terumo Aortic announces US FDA approval for Thoraflex Hybrid device
Terumo Aortic has announced that the US Food and Drug Administration (FDA) has granted approval of the Thoraflex Hybrid frozen elephant trunk (FET) device for commercial sale in the USA for the treatment of patients with complex aortic arch disease.
2. Cydar Medical announces strategic collaboration with Medtronic
Cydar Medical recently announced it has entered a strategic collaboration with Medtronic. Under the pilot arrangement, Cydar’s EV Maps software will be introduced to up to 40 new global sites, combining Cydar’s augmented intelligence technology with Medtronic’s services and case support, with the goal of improving patient care.
3. Cook Medical receives FDA Breakthrough Device designation for Zenith Thoraco+ endovascular system
Cook Medical’s Zenith Thoraco+ endovascular system (Thoraco+) has received Breakthrough Device designation from the US Food and Drug Administration (FDA), a press release reports. The Thoraco+ is the second product from Cook Medical to receive a Breakthrough Device designation in 2022.
4. Data from new VOYAGER PAD analyses reinforce benefit of Xarelto plus aspirin in patients with PAD and various comorbid conditions
The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced data from new analyses from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefit of the Xarelto (rivaroxaban) vascular dose (2.5mg twice daily plus aspirin 100mg once daily) in reducing severe vascular events in patients with PAD after lower-extremity revascularisation (LER).
5. ACC.22: Three-year data show “durable blood pressure reductions” through renal denervation
Long-term data from the first 80 patients in the SPYRAL HTN-ON MED trial have been presented during a featured clinical research session at the American College of Cardiology’s annual scientific sessions (ACC.22, 2–4 April, Washington DC, USA).
6. Medtronic issues voluntary recall for subset of IN.PACT Admiral and IN.PACT AV DCBs due to pouch damage
Medtronic recently voluntarily recalled a subset of its IN.PACT Admiral and IN.PACT AV paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheters due to the potential for pouch damage resulting in a loss of sterility. This is according to a news alert from the company dated 31 March.
7. Cordis makes strategic investment in E2, a developer of next-generation thrombectomy devices
Cordis has announced a strategic investment venture that will expand the scope of the global cardiovascular technology company into the venous thromboembolism (VTE) market with a strategic investment in Endovascular Engineering (E2), a developer of next-generation thrombectomy devices to treat patients with deep vein thrombosis (DVT) and pulmonary embolism (PE).
8. Truvic announces US FDA 510(k) clearance for Prodigy thrombectomy system
Truvic Medical, a wholly owned subsidiary of Imperative Care, announced in a press release that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Prodigy thrombectomy system, designed for the treatment of peripheral vascular thrombus.
9. Alucent Biomedical anounces first patient enrolled in first-in-human natural vascular scaffolding clinical trial
Alucent Biomedical announced in a press release that it has enrolled the first patient in ACTIVATE II, an Australia-based first-in-human clinical trial to evaluate the safety and efficacy of its natural vascular scaffolding (AlucentNVS) technology. The therapy is designed to open vessels and maintain patency without the use of permanent implants for the treatment of peripheral artery disease (PAD) of the lower extremities.
10. Corindus relocates Massachusetts headquarters to accommodate company growth
Corindus, a Siemens Healthineers company, announced the opening of its new headquarters at 275 Grove Street in Newton, USA. Siemens Healthineers relocated the Corindus headquarters from its previous location in Waltham, USA to accommodate company growth, doubling the size of the current location from 35,000 to 77,000 square feet, according to a company press release.