The Rotarex S rotating atherectomy system, which is now accessible in the United States, Europe, and other worldwide areas, is intended for use in acute, subacute, and chronic vascular blockages. The rotarex atherectomy S system, which uses specially engineered synchronised mechanisms of action, offers doctors with a single device to tackle even complicated lesions, all with a tiny equipment footprint that sets up in minutes.
The Aspirex S thrombectomy device is designed to remove thrombotic particles from blood arteries continuously. The Aspirex S is presently accessible in Europe and other parts of the world. Additional adjuvant drugs used in the treatment of PAD and venous disease are also included in the portfolio.
This purchase enables BD to deploy innovative technologies in both atherectomy and thrombectomy immediately, and it adds to BD's existing robust portfolio of drug-coated, angioplasty and scoring balloons, stents, stent grafts, and CTO crossing devices for the treatment of PAD and venous illness.
"With our significant expertise in endovascular technology and strong global infrastructure, BD is the appropriate firm to bring Straub Medical's atherectomy and thrombectomy solutions to market," said Steve Williamson, BD's global president of Peripheral Intervention. "We are dedicated to enhancing the quality of life for the more than 200 million people globally impacted by PAD and to provide more tools to help with the problems of managing venous illness." This purchase enables us to assist professionals in treating an additional number of patients."
Medtronic is recalling the HawkOne atherectomy system due to the possibility of tip damage during use.
Medtronic Inc. is recalling its HawkOne Directional Atherectomy System owing to the possibility of the guidewire within the catheter sliding lower or prolapsing during usage. If this occurs, the catheter tip may break off or separate, which may result in serious adverse events such as a tear along the inside wall of an artery (arterial dissection), a rupture or breakage of an artery (arterial rupture), a decrease in blood flow to a part of the body due to a blocked artery (ischemia), and/or blood vessel complications that may necessitate surgical repair and additional procedures to capture and remove the detached and/or migrated
According to the United States Food and Drug Administration (FDA), there have been 163 complaints regarding this device problem. There have been 55 documented injuries and no deaths as a result of this device malfunction.
This is a Class I recall, the most serious form of recall, according to the FDA. The usage of these devices can result in significant injury or death.A catheter and a cutter driver comprise the HawkOne Directional Atherectomy System. This gadget is used in operations to clear blockages in peripheral arteries and enhance blood flow.In the United States, 95,110 devices have been recalled. Between January 2018 and October 4, 2021, these were distributed. The recall was initiated by the seller on December 6, 2021.
Revolution Peripheral Atherectomy System Receives 510(k) Approval from Rex Medical
The results from the REVEAL IDE clinical study was used to get regulatory approval. In 121 participants with femoropopliteal/tibial occlusive disease, the findings of this pivotal study confirmed the safety and efficiency of the Revolution Peripheral Atherectomy System for lower extremity peripheral artery revascularization. The trial fulfilled all of its primary and secondary safety and efficacy goals.
In patients with occlusive atherosclerotic disease, the Revolution device is appropriate for peripheral vasculectomy as well as breaking up and removing thrombus from the peripheral arteries.
The Rex Medical Revolution Peripheral Atherectomy System is a low-profile rotational atherectomy system (140,000 RPM) with continuous mechanical aspiration for below-the-knee (BTK) and above-the-knee (ATK) applications, including thrombus and soft plaque, as well as severely calcified lesions and chronic total occlusions (CTOs). This gadget is powered by a 72 watt power source that is similar in size to a laptop computer charger and requires no capital equipment and only a few minutes to set up before usage.