Buerger's test

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: 
Tuesday, November 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.

First Round of Late-Breaking Clinical Trial Results Announced at VIVA23

Retrieved on: 
Tuesday, October 31, 2023

Below are highlights of this morning's 5 late-breaking clinical trial presentations.

Key Points: 
  • Below are highlights of this morning's 5 late-breaking clinical trial presentations.
  • At 20 centers without roll-ins across the United States, 105 no-option CLTI patients were enrolled in a nonrandomized manner.
  • The median age was 70 years, two-thirds of the patients were male, and one-quarter of patients were Hispanic or Latino.
  • 1-Year Results of the DEEPER OUS Trial: The Bare Temporary Spur Stent System in Combination With a Paclitaxel-Coated Balloon
    The DEEPER OUS trial is a prospective, nonrandomized, multicenter, single-arm trial taking place in New Zealand, Germany, and Switzerland.

Merck Initiates Phase 3 Clinical Program for Oral PCSK9 Inhibitor Candidate MK-0616

Retrieved on: 
Friday, August 25, 2023

This is the first Phase 3 clinical program for an oral PCSK9 inhibitor.

Key Points: 
  • This is the first Phase 3 clinical program for an oral PCSK9 inhibitor.
  • Merck also plans to initiate a Phase 3 cardiovascular outcomes study, CORALreef Outcomes by the end of 2023.
  • Merck is collaborating with the TIMI Study Group, a leading academic research organization for cardiovascular clinical trials, on the CORALreef Outcomes study.
  • Merck’s broad, global Phase 3 program for MK-0616 aims to enroll approximately 17,000 participants across the CORALreef Lipids, CORALreef HeFH and CORALreef Outcomes studies.

Penumbra Expands Computer-Aided Thrombectomy Offerings with Lightning Bolt 7 Technology Designed to Rapidly Remove Blood Clots with Modulated Aspiration

Retrieved on: 
Thursday, June 1, 2023

Lightning Bolt 7 introduces a new method for removing blood clots, modulated aspiration, which pairs Penumbra's Lightning Intelligent Aspiration technology with an advanced microprocessor algorithm.

Key Points: 
  • Lightning Bolt 7 introduces a new method for removing blood clots, modulated aspiration, which pairs Penumbra's Lightning Intelligent Aspiration technology with an advanced microprocessor algorithm.
  • When used together, Lightning Bolt 7 is designed to enhance the ability to rapidly remove large, fibrous blood clots in the arteries with minimal blood loss, addressing conditions such as acute limb ischemia (ALI), hibernating thrombus and visceral occlusions.
  • "Advancements like Lightning Bolt 7 provide a critical frontline option for physicians to treat patients and improve patient outcomes."
  • Powered by the Penumbra ENGINE®, Lightning Bolt 7 is engineered to detect the difference between blood clot and blood flow.

Surmodics Announces First Patient Enrolled in PROWL Registry Study Using the Pounce™ Thrombectomy System

Retrieved on: 
Thursday, April 20, 2023

Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced enrollment of the first patient in PROWL, the Pounce™ Thrombectomy System Retrospective Registry.

Key Points: 
  • Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced enrollment of the first patient in PROWL, the Pounce™ Thrombectomy System Retrospective Registry.
  • PROWL is an open-label, retrospective, multi-center, U.S. registry of the Surmodics Pounce system for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature.
  • The first site to enroll a patient in the registry study was Baton Rouge General Medical Center, Baton Rouge, La.
  • We are confident the PROWL registry will demonstrate these exceptional attributes of the Pounce system in real-world clinical practice.”