News | Atherectomy Devices | July 18, 2018

First U.S. Patients Treated With Second-Generation Pantheris Atherectomy Device

More than 40 patients treated for peripheral artery disease across 13 U.S. sites

First U.S. Patients Treated With Second-Generation Pantheris Atherectomy Device

July 18, 2018 — Avinger Inc. announced in June that several physicians have successfully treated over 40 patients for peripheral artery disease (PAD) in the United States across 13 sites with the next-generation Pantheris image-guided atherectomy system. This positive initial case experience in the U.S. adds to the impressive clinical results achieved in the first 30 cases completed in Germany earlier this year and provides a strong foundation for expanded market launch into all U.S. accounts, according to the company.

The next-generation Pantheris design includes:

  • A simplified single balloon system for cutter apposition and blood flow management;
  • A stiffer shaft for increased pushability;
  • A more robust nosecone with the option for more tissue storage capacity; and
  • An enhanced cutter design.

These primary feature improvements and other small advancements are intended to augment the performance and reliability of the device. According to Avinger, they have thus far resulted in very positive acute outcomes across a variety of lesion types, including heavily calcified disease, chronic total occlusions, and in arteries above and below the knee.

Glen Schwartzberg, M.D., a vascular surgeon at Baton Rouge General in Louisiana, was the first physician in the United States to use both versions of the next-generation device, the Pantheris A400 standard nosecone and Pantheris A400X extended nosecone, in separate cases. Summarizing his initial experiences on the new Lumivascular platform, Schwartzberg commented, “I am very excited about the outcomes for patients that the next-generation Pantheris has helped me achieve in my initial 10 cases. Since the infancy of this technology, I have always thought onboard image-guided atherectomy represented the future of endovascular intervention for many types of disease because of its ability to target specific pathology as opposed to other atherectomy devices which indiscriminately engage both normal and abnormal tissue, potentially creating harm. While still early in our experience with the device, the new design features have already expanded the applicability of Pantheris to a wider variety of lesion types, and I have observed a marked improvement in cutting efficiency and ease of use. I use Pantheris as my front-line therapy due to its safety profile with the reduction of radiation and contrast delivery to the patient and my firm belief that this approach will generate better long-term results for patients. The data from the VISION trial with the first-generation Pantheris demonstrated the longer-term efficacy and safety of this therapy, and the body of evidence should only grow from here.”

Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology allows physicians to see from inside the artery during an atherectomy procedure by using an imaging modality called optical coherence tomography (OCT) that is displayed on Avinger’s proprietary Lightbox console. Physicians performing atherectomy with other devices must rely solely on X-ray as well as tactile feedback to guide their interventions while treating complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, thanks to the real-time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionizing radiation.

For more information: www.avinger.com

Related Content

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
Avinger, VISION Study, two-year outcomes, LINC, Lumivascular technology, Pantheris, OCT-guided atherectomy
News | Atherectomy Devices | February 03, 2017
Avinger Inc. recently announced positive two-year clinical data from the pivotal VISION study of the company’s...
Overlay Init