News | 06.25.20
Medicare Advantage Database Analysis Finds No Evidence of Increased Long-Term Mortality After Paclitaxel Device Treatment
June 25, 2020—An analysis of Medicare Advantage patients who underwent femoropopliteal artery revascularization from April 2015 through December 2017 found no evidence of increased long-term mortality in those treated with paclitaxel-based devices, according to new data presented by Eric A. Secemsky, MD, MSc, during a VIVA Late-Breaking Trials Livestream.
News | 06.25.20
MERLION Study Evaluates Early Outcomes of iVascular's Luminor DCB to Treat TASC C and D Tibial Disease
June 25, 2020—Professor Tjun Tang, MD, presented interim 6-month results from the MERLION study exploring the iVascular Luminor drug-coated balloon (DCB) in infrapopliteal atherosclerotic lesions in chronic limb threatening ischemia (CLTI) patients with a high incidence of diabetes mellitus (DM) and end-stage renal failure (ESRF).
News | 06.25.20
One-Year TOBA II BTK Data Presented for Intact Vascular's Tack Endovascular System (4F)
June 25, 2020—Intact Vascular, Inc. announced that 1-year results from the Tack Optimized Balloon Angioplasty II Below-the-Knee (TOBA II BTK) clinical trial were presented online by coprincipal investigator Patrick Geraghty, MD, during the 2020 Vascular Interventional Advances (VIVA) Late-Breaking Clinical Trial livestream.
News | 06.22.20
Rexgenero Acquires Aratinga.bio SAS Group's Key Technology and Program Assets
June 22, 2020—Rexgenero Ltd., a United Kingdom-based regenerative medicine company developing cell therapies to treat chronic limb-threatening ischemia, announced the acquisition of all the key assets of aratinga.bio SAS Group, a preclinical-stage immunotherapy biotech company based in Paris, France.
News | 06.16.20
Infinity Angioplasty Balloon Catheter Receives 510(k) Clearance
June 16, 2020—Infinity Angioplasty Balloon Co., LLC announced that the FDA has cleared the Infinity angioplasty balloon catheter for percutaneous transluminal angioplasty treatment of peripheral arterial disease in the peripheral vasculature, including iliac, femoral, popliteal, and infrapopliteal arteries, and for the treatment of arteriovenous dialysis fistulas.
News | 06.15.20
European IFUs for Paclitaxel-Coated Devices Will Contain New Warning
June 15, 2020—Manufacturers and marketers of paclitaxel-coated balloons and stents used in the treatment of lower extremity peripheral arterial disease are issuing a Field Safety Notice regarding updates to the indications for use (IFU) for these devices throughout Europe.
News | 06.08.20
Shockwave Medical Announces New CMS Codes for Reimbursement of Intravascular Lithotripsy Procedures
June 8, 2020—Shockwave Medical, Inc. announced that the Centers for Medicare & Medicaid Services (CMS) has issued new codes for intravascular lithotripsy (IVL) procedures performed in peripheral arteries in the hospital outpatient and inpatient settings to treat complex calcified cardiovascular disease.
News | 06.05.20
BD Launches Halo One Thin-Walled Guiding Sheath
June 5, 2020—BD (Becton, Dickinson and Company) announced the launch of the Halo One thin-walled guiding sheath, which is designed to perform as both a guiding sheath and an introducer sheath for use in peripheral artery and venous procedures requiring percutaneous introduction of intravascular devices.
News | 06.04.20
FDA Clears Transit Scientific’s XO Score Angioplasty Scoring and Cutting Platform
June 4, 2020—Transit Scientific announced FDA clearance for the XO Score percutaneous transluminal angioplasty (PTA) scoring sheath platform for use in iliac, iliofemoral, popliteal, infrapopliteal, and renal artery disease plus synthetic and/or native arteriovenous hemodialysis fistula.
News | 05.27.20
Enrollment Begins in ACTIVATE I Study of Alucent NVS Vessel Restoration System
May 27, 2020—Alucent Biomedical Inc. announced that it has enrolled the first two patients in ACTIVATE I, a phase 1 clinical trial to evaluate the safety and efficacy of its Natural Vascular Scaffolding (NVS) technology for the treatment of peripheral artery disease (PAD) of the lower extremities.
News | 05.12.20
Micro Medical Solutions Begins Pivotal STAND Trial of MicroStent to Treat BTK Arterial Disease
May 12, 2020—Micro Medical Solutions (MMS) announced the first implantation of the company’s MicroStent vascular stent in STAND, the randomized, multicenter pivotal clinical study to support FDA approval of the device to treat arterial disease below the knee.
News | 05.06.20
Getinge Introduces Larger-Diameter Advanta V12 Balloon-Expandable Covered Stent to Treat Iliac Artery Disease
May 6, 2020—Getinge announced the commercial introduction of a larger-diameter Advanta V12 balloon-expandable covered stent, which expands from 12 to 16 mm, to treat iliac arterial occlusive disease.
News | 05.03.20
Adjusted and Case-Matched Analysis Evaluates Association of Paclitaxel and Mortality After Peripheral Angioplasty
May 3, 2020—An adjusted and case-matched multicenter analysis of paclitaxel and mortality after peripheral angioplasty found that when relevant risk factors were taken into account, there were no associations between paclitaxel and midterm mortality in patients with peripheral arterial occlusive disease (PAOD).
News | 04.30.20
Cook Medical Will Distribute New Surmodics PTA Balloon Catheters for CLI
April 30, 2020—Cook Medical and Surmodics, Inc. announced an agreement in which Cook Medical will distribute two new Surmodics hydrophilic percutaneous transluminal angioplasty (PTA) balloon catheters that can be used over 0.014- and 0.018-inch wire guides.
US Device Guide
This Device Guides offers a searchable, comprehensive listing of the available vascular interventional devices in the United States.
European Device Guide
This Device Guides offers a searchable, comprehensive listing of the available vascular interventional devices in Europe.