| Developers: | AngioDynamics |
| Date of the premiere of the system: | August 2023 |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
Content |
2024: AlphaVac F18 System Announcement for Pulmonary Embolism
At the end of September 2024, AngioDynamics announced the start of a clinical study of the AlphaVac F18 system for the treatment of pulmonary embolism (PE). The AlphaVac F18 system is a mechanical aspiration device for emergency care that allows non-surgical removal of thrombotic clots from the pulmonary arteries. The device is equipped with an ergonomic handle, 18F cannula with an angle of 85 degrees, an obturator and an assembly of a waste bag.
A new international study will evaluate the efficacy, safety and long-term outcomes of the AlphaVac F18 system, which is designed for percutaneous thrombus removal. First of all, the system will be used for acute moderate risk PE for further implementation on the European market. AlphaVac F18 already received CE approval in May 2024, just a month after registering in the U.S.
The new European study RECOVER-AV will complement the results of the American study, which involved 122 patients. The RECOVER-AV study will be conducted at 20 clinical centers in Europe, a reduction in the ratio of right ventricular volume to left ventricular volume (RV/LV) will be used to evaluate efficacy 48 hours after the procedure from baseline, and a reduction in the incidence of serious adverse events, including device-related death or massive bleeding within seven days of surgery, will be used to assess safety.
AngioDynamics said researchers plan to monitor patients for 12 months. They will evaluate the functional outcomes of surgery after 30 days, six months and 12 months. This is the first international study AngioDynamics intends to sponsor to bring its products to market.[1]
2023: Product Announcement
On August 15, 2023, the company AngioDynamics announced the AngioVac system, designed for non-surgical removal blood clots from the right departments. hearts
AngioVac is an aspiration system that uses a venous drainage cannula to remove blood clots or embols during extracorporeal bypass surgery of up to six hours. The solution makes it possible to remove blood clots and embolic material, minimizing blood loss due to the recirculation of blood through the veno-venous bypass circuit. Target vessels include, but are not limited to, the iliofemoral vein, inferior vena cava, and superior vena cava.
It is noted that the US Food and Drug Administration (FDA) has assigned the AngioVac system the designation "Breakthrough Device." This means that the novelty is able to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases and conditions for which there are no alternative methods of therapy.
The AngioVac system is a loop with two large diameter catheters connected to a centrifugal pump. One of the catheters with a funnel-shaped tip is directed to a thrombus, after which it is aspirated into a cardiopulmonary pump. The blood clot is held inside the pump and the aspirated blood is returned to the patient through a second venous catheter. A requirement for effective operation of the AngioVac system is the presence of a perfusiologist who must maintain pump operation during thrombus aspiration.
 | Recognizing AngioVac and its potential as an innovative method for the non-surgical removal of blood clots from the right heart represents an important step towards improving patient care, "said Jim Clemmer, President and CEO of AngioDynamics.[2] |  |
Notes
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