The US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) to Amplitude Vascular Systems (AVS), greenlighting a pivotal trial investigating the company’s pulsatile intravascular lithotripsy therapy.
The POWER-PAD-II clinical study will evaluate the safety and efficacy of AVS’s device, named the Pulse IVL System, for the treatment of patients with severely calcified peripheral arterial disease.
Peripheral artery disease is the narrowing or blockage of vessels caused by atherosclerosis. The condition affects around eight to 12 million people in the US.
The trial aims to enrol up to 120 patients with peripheral artery disease in the US. Patients will be followed for up to six months after the therapy.
Pulsatile intravascular lithotripsy uses sound waves to break up calcified portions of vessels. The high-frequency, pulsatile pressure fragments calcium lesions and helps restore vessel patency. There is currently no FDA-approved device that uses this approach for peripheral artery disease treatment.
AVS board chairman Mark Toland said: “The IDE approval marks our most significant clinical milestone to date as we approach FDA clearance and market availability for the Pulse IVL System, which is designed to easily deliver therapy across complex calcified lesions and reduce overall procedural costs.”
Access the most comprehensive Company Profiles
on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Company Profile – free
sample
Your download email will arrive shortly
We are confident about the
unique
quality of our Company Profiles. However, we want you to make the most
beneficial
decision for your business, so we offer a free sample that you can download by
submitting the below form
By GlobalData
<!–
–>
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
The POWER-PAD-II clinical study follows the company’s POWER-PAD-I study (NCT05192473), which demonstrated positive efficacy in patients with calcific femoropopliteal arteries. The system reduced leg pain, increased blood flow and improved walking ability.
Also in the calcified lesion space is Elixir Medical, which, similar to AVS, is developing an intravascular lithotripsy system. The company revealed positive safety and effectiveness data for its LithiX Hertz Contact device last month.
A range of novel devices are in development for the treatment of peripheral artery disease. Becton, Dickinson and Company (BD) enrolled the first subject in a study evaluating its vascular-covered stent in March this year. ReFlow Medical has reported positive data from its retrievable stent, indicated for the treatment of vascular lesions in the infrapopliteal arteries below the knee.
<!– –>
- SEO Powered Content & PR Distribution. Get Amplified Today.
- PlatoData.Network Vertical Generative Ai. Empower Yourself. Access Here.
- PlatoAiStream. Web3 Intelligence. Knowledge Amplified. Access Here.
- PlatoESG. Carbon, CleanTech, Energy, Environment, Solar, Waste Management. Access Here.
- PlatoHealth. Biotech and Clinical Trials Intelligence. Access Here.
- Source: https://www.medicaldevice-network.com/news/avs-secures-ide-from-fda-for-pulsatile-intravascular-lithotripsy-trial/
