PAD

CardioVascular Coalition Calls for Immediate Congressional Action to Prevent Further Clinical Labor Cuts

Retrieved on: 
星期二, 十一月 14, 2023

WASHINGTON, Nov. 14, 2023 /PRNewswire-PRWeb/ -- Today, the CardioVascular Coalition (CVC) – a coalition of physicians, care providers, advocates, and manufacturers — is calling on Congress to step in and stop the cuts to revascularization services included in the finalized 2024 Medicare Physician Fee Schedule (MPFS) Rule.

Key Points: 
  • "We are asking for Congress to step in and stop these cuts from harming patients and forcing providers to close their doors.
  • 3674 is a bipartisan solution that can pass before the end of the year, but Congress must make this a priority."
  • These year-over-year cuts are being implemented without regard to patient outcomes, actual PFS provider resource needs, or any other rationale policy.
  • The CardioVascular Coalition (CVC) strongly supports the Providing Relief and Stability for Medicare Patients Act of 2023 (H.R.

New VOYAGER PAD Analyses Reinforce Benefit of XARELTO® (rivaroxaban) Plus Aspirin Across High-Risk and Complex Patient Populations with Peripheral Artery Disease (PAD)

Retrieved on: 
星期二, 十一月 14, 2023

TITUSVILLE, N.J., Nov. 14, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from two new analyses from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefit of XARELTO® (rivaroxaban [2.5 mg twice daily plus aspirin 100 mg once daily]) over standard of care (aspirin alone). Data from the two analyses demonstrate the role of XARELTO® in treating both high-risk and fragile patients and those with and without comorbid coronary artery diseases (CAD). Results were presented at the American Heart Association's (AHA) 2023 Scientific Sessions, hosted in Philadelphia, Pennsylvania, November 11-13, 2023.

Key Points: 
  • "These analyses reinforce the consistency of the favorable benefit-risk profile of XARELTO® plus aspirin for patients with vascular disease, regardless of comorbidity.
  • In fragile patients treated with XARELTO® plus aspirin, 6.2% of patients experienced a MALE compared to 10.3% of patients treated with placebo.
  • In patients with PAD only, 11% of patients treated with XARELTO® plus aspirin experienced a MACE versus 9.8% of patients treated with placebo.
  • Overall, the safety of XARELTO® plus aspirin in patients with PAD was consistent regardless of CAD with no significant interactions.

Truveta announces availability of millions of echocardiogram reports to advance cardiovascular research

Retrieved on: 
星期三, 十一月 8, 2023

BELLEVUE, Wash., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Today Truveta announced the availability of more than 56.6 million clinical observations from more than 2.7 million echocardiogram reports from more than 1.7 million de-identified patients, making it the market leader in real-world data to advance cardiovascular research at scale.

Key Points: 
  • BELLEVUE, Wash., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Today Truveta announced the availability of more than 56.6 million clinical observations from more than 2.7 million echocardiogram reports from more than 1.7 million de-identified patients, making it the market leader in real-world data to advance cardiovascular research at scale.
  • New peer-reviewed research using Truveta Data was published recently in the Journal of the Society for Cardiovascular Angiography and Interventions (JSCAI) comparing two treatments for pulmonary embolism and identifying risk for adverse events like major bleeding.
  • Existing methods, such as relying on registry data or physician referrals, have limitations in scope and timeliness, hindering large-scale research.
  • The availability of these data has the potential to propel cardiovascular research forward in ways never before possible, opening new horizons of discovery and innovation to improve patient care and outcomes and save lives."

Shufti Pro Recognised as a Sample Vendor for Identity Verification in the Gartner® Hype Cycle™ for Digital Identity, 2023

Retrieved on: 
星期三, 十一月 8, 2023

Shufti Pro has been recognised as a sample vendor in the Gartner Hype Cycle for Digital Identity 2023, published on July 26th, 2023.

Key Points: 
  • Shufti Pro has been recognised as a sample vendor in the Gartner Hype Cycle for Digital Identity 2023, published on July 26th, 2023.
  • Shufti Pro was mentioned at the bottom of the page under “Sample Vendors” on Page 59, among other Sample Vendors.
  • This includes identity verification and data-centric identity affirmation.”
    Shufti Pro assures businesses that only trusted and real people can pass verification, with up to a 99.7% accuracy rate.
  • Gartner, Hype Cycle for Digital Identity, 2023, 26 July 2023.

VentureMed Receives Transitional Pass-through Payment (TPT) for FLEX Vessel Prep™ System

Retrieved on: 
星期三, 十一月 8, 2023

The pass-through payment provides outpatient facilities with an incremental Medicare payment for procedures in which FLEX VP is utilized.

Key Points: 
  • The pass-through payment provides outpatient facilities with an incremental Medicare payment for procedures in which FLEX VP is utilized.
  • "CMS approval of a TPT for VentureMed's FLEX Device is monumental and will provide access of this novel technology to many deserving patients.
  • This new C-code supports access for our FLEX Vessel Prep System for hospitals and Ambulatory Service Center (ASC's)," said Denis Harrington, VentureMed's President and CEO."
  • This approval was granted in part based on FLEX Vessel Prep meeting CMS criteria for substantial clinical improvement over the existing standard of care.

Occlusion Perfusion Catheter Demonstrates Superior Performance in PAD Drug Delivery

Retrieved on: 
星期四, 十一月 2, 2023

CHATTANOOGA, Tenn., Nov. 02, 2023 (GLOBE NEWSWIRE) -- The Occlusion Perfusion Catheter (OPC), a multi-lumen balloon catheter from Advanced Catheter Therapies (ACT), was recently selected by researchers for use in exploring a new treatment approach for peripheral artery disease (PAD) and restenosis.

Key Points: 
  • CHATTANOOGA, Tenn., Nov. 02, 2023 (GLOBE NEWSWIRE) -- The Occlusion Perfusion Catheter (OPC), a multi-lumen balloon catheter from Advanced Catheter Therapies (ACT), was recently selected by researchers for use in exploring a new treatment approach for peripheral artery disease (PAD) and restenosis.
  • Sirolimus is currently being explored as an alternative drug to paclitaxel for the treatment of PAD.
  • To date, sirolimus has only been used as drug coatings for stents and balloons and no studies have yet demonstrated the delivery of sirolimus in liquid form.
  • “ Pre-clinical investigation of liquid sirolimus for local drug delivery ” was published September 15, 2023, in Frontiers in Cardiovascular Medicine .

Aware® Reports Third Quarter and Nine Month 2023 Financial Results

Retrieved on: 
星期三, 十一月 1, 2023

BURLINGTON, Mass., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Aware, Inc. (NASDAQ: AWRE), a global biometric platform company that uses data science, machine learning, and artificial intelligence to tackle everyday business and identity challenges through biometrics, today reported financial results for the third quarter ended September 30, 2023.

Key Points: 
  • Total revenue for the third quarter of 2023 increased 112% to $6.4 million compared to $3.0 million in the third quarter of 2022.
  • Operating cashflow for the third quarter of 2023 totaled $2.5 million, compared to cash usage of $2.0 million in the same year-ago period.
  • Net income for the third quarter of 2023 totaled $1.1 million, or $0.05 per diluted share.
  • Adjusted EBITDA (a non-GAAP metric reconciled below) for the third quarter of 2023 totaled $0.4 million.

Endologix Announces Results of Pooled Analysis of DETOUR1 and DETOUR2 Studies at 2023 VIVA Late-Breaking Clinical Trial Session

Retrieved on: 
星期四, 十一月 2, 2023

Data were aggregated from DETOUR1 and DETOUR2, both of which were prospective, single-arm, multi-center, international studies designed to evaluate the DETOUR System.

Key Points: 
  • Data were aggregated from DETOUR1 and DETOUR2, both of which were prospective, single-arm, multi-center, international studies designed to evaluate the DETOUR System.
  • For the pooled analysis, primary patency was defined as freedom from target vessel revascularization (TVR).
  • “We are pleased to present the combined results of the DETOUR1 and DETOUR2 Studies.
  • Safety and Performance of percutaneous Transmural Femoropopliteal Bypass with the DETOUR System: Pooled analysis of DETOUR1 and DETOUR2.

LimFlow Announces Agreement to Be Acquired by Inari Medical

Retrieved on: 
星期三, 十一月 1, 2023

The LimFlow System is the first and only FDA-approved device for TADV and previously received Breakthrough Device Designation from the FDA.

Key Points: 
  • The LimFlow System is the first and only FDA-approved device for TADV and previously received Breakthrough Device Designation from the FDA.
  • "We are thrilled to join forces with Inari Medical, expanding the reach of our remarkable technology to bring renewed hope to patients who are currently suffering," said LimFlow CEO Dan Rose.
  • "Our heartfelt gratitude goes out to the exceptional LimFlow team, our dedicated clinical partners, and our investors who believed in our mission.
  • “The acquisition of LimFlow is closely aligned with our mission to address significant unmet patient needs and adds another highly differentiated growth platform into our portfolio,” said Drew Hykes, CEO of Inari.

Vibrato Medical Announces Positive Results for Early Feasibility Study of Wearable, Non-Invasive Therapeutic Ultrasound to Treat Chronic Limb-Threatening Ischemia (CLTI)

Retrieved on: 
星期三, 十一月 1, 2023

Vibrato Medical, an innovator in the treatment of peripheral arterial disease (PAD), announced today that data from an early feasibility study of Non-Invasive Therapeutic Ultrasound (TUS) to treat Chronic Limb-Threatening Ischemia (CLTI) has successfully met its endpoint.

Key Points: 
  • Vibrato Medical, an innovator in the treatment of peripheral arterial disease (PAD), announced today that data from an early feasibility study of Non-Invasive Therapeutic Ultrasound (TUS) to treat Chronic Limb-Threatening Ischemia (CLTI) has successfully met its endpoint.
  • The study evaluated patients with infrapopliteal PAD and measured changes in foot perfusion and oxygenation as well as therapy tolerance, compliance and perception.
  • Patients in the trial had Rutherford class 3, 4 or 5 PAD, meaning severe claudication, ischemic rest pain or tissue loss including nonhealing ulcers.
  • “These early findings are promising for the future of non-invasive therapeutic options to treat chronic limb-threatening ischemia,” said Juliana Elstad, CEO at Vibrato.