Technology | Atherectomy Devices | September 13, 2019

Rex Medical Receives 510(k) Clearance for Revolution Peripheral Atherectomy System

Rotational atherectomy system employs continuous mechanical aspiration for below-the-knee and above-the-knee applications

Rex Medical Receives 510(k) Clearance for Revolution Peripheral Atherectomy System

September 13, 2019 — Rex Medical L.P. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Revolution Peripheral Atherectomy System.

Regulatory clearance was based on data provided by the REVEAL IDE clinical trial. The results of this pivotal trial demonstrated the safety and effectiveness of the Revolution Peripheral Atherectomy System for lower extremity peripheral arterial revascularization in 121 subjects with femoropopliteal/tibial occlusive disease. The trial met all prespecified primary and secondary safety and effectiveness endpoints.

The Revolution device is indicated for atherectomy of the peripheral vasculature, and to break apart and remove thrombus from the peripheral arteries in patients with occlusive atherosclerotic disease.

Peripheral artery disease (PAD) and its most severe form, critical limb ischemia (CLI), affects more than 10 million people in the U.S. It occurs when an artery becomes blocked or narrowed due to plaque or calcium deposits, which in turn reduces blood flow to the lower extremities. Left untreated, this can result in pain, ulceration, gangrene and amputation. Successful revascularization and blood flow restoration is essential in the treatment and quality of life improvement for this patient population.

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 multiple plaque morphologies ranging from thrombus and soft plaque to severely calcified lesions and chronic total occlusions (CTOs). This device is operated by a 72 watt power supply similar in size to a laptop computer charger and requires no capital equipment and minimal setup time prior to use.

Jeffrey G. Carr, M.D., FACC, FSCAI, Tyler Cardiac and Endovascular Center, served as the study’s principal investigator and stated, “PAD and CLI are associated with significant patient quality of life and major health issues. The recent clearance of Revolution technology will assist the interventional community in the effective reduction of calcification and vessel preparation in multiple lesion morphologies prior to adjunctive therapy utilizing percutaneous transluminal angioplasty (PTA), drug-coated balloons and stenting. Continuous mechanical aspiration to reduce the potential for distal embolization is a distinct advantage associated with this technology. Intraprocedural embolization continues to be a key concern for many atherectomy procedures.”

Rex Medical President Lindsay L. Carter said the company anticipates obtaining CE Mark for the Revolution Peripheral Atherectomy System in the fourth quarter of 2019. 

For more information:

Related Content

First U.S. Patients Treated With Second-Generation Pantheris Atherectomy Device
News | Atherectomy Devices | July 18, 2018
Avinger Inc. announced in June that several physicians have successfully treated over 40 patients for peripheral artery...
Avinger Receives FDA Clearance of Next-Generation Pantheris Device
Technology | Atherectomy Devices | May 24, 2018
Avinger Inc. announced that the company received 510(k) clearance from the U.S. Food & Drug Administration (FDA)...
Medtronic Receives FDA Clearance for Riptide Aspiration System
Technology | Atherectomy Devices | January 16, 2018
Medtronic plc announced the company’s Neurovascular business unit received U.S. Food and Drug Administration (FDA)...
Avinger Announces Treatment of First Patients With Next-Generation Pantheris
News | Atherectomy Devices | January 09, 2018
January 9, 2018 – Avinger Inc. announced that Arne Schwindt, M.D., a vascular surgeon at St.
Avinger Receives 510(k) Clearance for Pantheris Image-Guided Atherectomy Device Modifications
Technology | Atherectomy Devices | November 20, 2017
November 20, 2017 — Avinger Inc. announced in October that the company received 510(k) clearance from the U.S.
Avinger Receives CE Mark for In-Stent Restenosis Indication With Pantheris Image-Guided Atherectomy
Technology | Atherectomy Devices | September 29, 2017
Avinger Inc. recently announced Conformité Européenne (CE) Marking approval for treating in-stent restenosis with the...
Ra Medical Systems Receives FDA Clearance for New Peripheral Artery Disease Treatment
Technology | Atherectomy Devices | May 30, 2017
The U.S. Food and Drug Administration (FDA) announced that it has granted market clearance to Ra Medical Systems for...
CSI recall for saline pump on its atherectomy system
News | Atherectomy Devices | April 19, 2017
Cardiovascular Systems Inc. (CSI) announced April 18 it had initiated a voluntary recall of its 7-10014 Saline Infusion...
Cardiovascular Systems Inc., CSI, ECLIPSE clinical trial, Diamondback 360 Coronary Orbital Atherectomy System, first subject enrolled
News | Atherectomy Devices | April 04, 2017
Cardiovascular Systems Inc., in partnership with the Cardiovascular Research Foundation (CRF), announced the first...
CSI, LIBERTY 360 Study, ISET 2017, six-month data, lower extremity PAD
News | Atherectomy Devices | February 08, 2017
February 8, 2017 — Cardiovascular Systems (CSI) presented six-month data from its LIBERTY 360° post-market study in a
Overlay Init