WAYNE, Pa.–(BUSINESS WIRE)– Cagent Vascular, a developer of next generation technology for vessel dilatation in cardiovascular disease interventions, announces the issuance of its CE Marking for the Serranator® PTA Serration Balloon Catheter. Cagent Vascular has also achieved its ISO 13485 Certification. The Serranator® is one of a family of peripheral artery disease (PAD) […]
Peripheral/Endo
Positive Twenty-Four Month Tack Optimized Balloon Angioplasty (“TOBA”) Single Center Results Presented at VEITHsymposium™ Conference
WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally-invasive peripheral vascular procedures, today announced that positive single center twenty-four month results from its Tack Optimized Balloon Angioplasty (TOBA) clinical study were presented at the VEITHsymposium™ 2017 conference by Dr. Christian Wissgott, Assistant Director, at Westküstenklinikum Heide in Heide, Germany. The TOBA study enrolled […]
Aziyo Presents Positive Initial Data From Clinical Study of Biologic Extracellular Matrix Scaffold for Femoral Arterial Reconstruction
SILVER SPRING, Md.–(BUSINESS WIRE)– Aziyo Biologics, a fully integrated regenerative medicine company, today announced positive results from PERFORM, a prospective, post-market study conducted in patients undergoing femoral arterial reconstruction using the company’s biologic extracellular matrix (ECM) scaffold. There were no device-related adverse events or infections and primary patency was maintained in 97.6% of […]
Bay Area’s Avinger Axes Jobs, Q3 Sales Down 61%
Beleaguered Avinger, Inc. is slashing more jobs. In its latest financial disclosure, Avinger reported a 61 percent decline in sales since the same time last year and would continue its strategic reorganization to save cash. The company said headcount has been reduced to 73 employees as of Oct. 15. That number includes […]
Medtronic gains new CPT codes for Venous device in 2018
Medtronic’s VenaSeal Closure System Receives New CPT Codes By Endovascular Today November 13, 2017—Medtronic has advised that their VenaSeal closure system received a favorable new CPT code as a Level 4 vascular procedure as part of the calendar year 2018 Medicare Physician Fee Schedule and Hospital Outpatient Prospective Payment and Ambulatory Surgical Center […]
Vascular Therapies Announces Preliminary Results From its Phase III AV Fistula Study
CRESSKILL, N.J., Nov. 9, 2017 /PRNewswire/ — An innovative, investigational treatment approach is showing the potential to address an important, unresolved problem encountered by patients with kidney failure on dialysis. At the recent annual meeting of the American Society of Nephrology (ASN), Vascular Therapies, Inc. presented preliminary results relating to […]
Postmarket Surveillance Study Confirms Benefits of Cook Medical’s Zilver® PTX® Drug Eluting Stent at 12 Months in Japanese Patients
LAS VEGAS–(BUSINESS WIRE)–One-year post-market surveillance (PMS) study data from Japanese patients who received the Zilver® PTX® drug-eluting stent confirmed the benefits of the device at 12 months, researchers announced today. Japanese researchers presented the PMS study results at themeeting in Las Vegas. This was the first time the study has been presented […]
Symic Bio Announces Results from the Phase 1/2 SHIELD Trial of SB-030 in Peripheral Vascular Disease
SAN FRANCISCO, Nov. 1, 2017 /PRNewswire/ — Symic Bio, a biopharmaceutical company developing novel matrix-targeting biotherapeutics, today announced results from the Phase 1/2 SHIELD trial evaluating SB-030, a locally administered therapeutic, in patients with peripheral vascular disease undergoing angioplasty. In this first-in-human, prospective, randomized, single-blind controlled study of 67 patients, SB-030 demonstrated a […]
Mercator MedSystems Announces Completion of Enrollment in the LIMBO-ATX Trial
EMERYVILLE, Calif., Oct. 30, 2017 /PRNewswire/ — Mercator MedSystems, Inc., a medical technology company specializing in localized delivery of drug therapies for deep in the body, announced completion of enrollment today in the company’s LIMBO-ATX (Lower-Limb Adventitial Infusion of Dexamethasone via Bullfrog to Reduce Occurrence of Restenosis after Atherectomy-Based Revascularization) clinical […]
Nitiloop Announces FDA 510(k) Clearance for its Nova Cross Extreme and Nova Cross BTK Micro catheter for Support of Guidewire Access to Discrete Regions of the Coronary and Peripheral Vasculature
NETANYA, Israel, October 26, 2017 /PRNewswire/ — Nitiloop, a medical device company dedicated to the development of Cardiovascular and peripheral microcatheters for complex lesions, received FDA clearance for its new Nova Cross™ Extreme and Nova Cross™ BTK. These dedicated microcatheters are joining the Nova Cross™ product family combining innovative low profile microcatheter technology with uniquely designed Nitinol scaffold providing […]