TEVAR

Vivasure Medical Announces First Patients Treated with PerQseal Elite Closure Device System

Retrieved on: 
Tuesday, December 12, 2023

Vivasure Medical® , a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the first patient treated with PerQseal® Elite, the latest generation of the company’s fully absorbable large-hole closure system.

Key Points: 
  • Vivasure Medical® , a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the first patient treated with PerQseal® Elite, the latest generation of the company’s fully absorbable large-hole closure system.
  • Ph.D., at Erasmus University Hospital in Rotterdam, The Netherlands, as part of the company’s ELITE Study—a prospective, multi-center, single-arm clinical study evaluating the safety and efficacy of PerQseal Elite.
  • PerQseal Elite leverages the legacy PerQseal system’s excellent safety profile and ease of use.
  • The company continues to enroll patients for its Investigational Device Exemption (IDE) clinical study for PerQseal and PerQseal+ in the United States.

Vivasure Medical Announces 100th Patient Enrolled in U.S. Pivotal Study

Retrieved on: 
Tuesday, November 14, 2023

Vivasure Medical® , a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has enrolled the 100th patient in its PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and efficacy of the Vivasure PerQseal® Closure Device System.

Key Points: 
  • Vivasure Medical® , a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has enrolled the 100th patient in its PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and efficacy of the Vivasure PerQseal® Closure Device System.
  • The U.S. Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval earlier this year to advance the PATCH study forward.
  • “We’re grateful to the one hundred patients who have been enrolled in this study to date and the brilliant physician investigators working to gather data about our technology,” said Andrew Glass, Chief Executive Officer of Vivasure Medical.
  • The PATCH pivotal study will enroll and follow up to 188 patients across the U.S. and Europe.

Vivasure Medical Announces Enrollment of First Patients in Pivotal PATCH Study

Retrieved on: 
Tuesday, May 2, 2023

Vivasure Medical® , a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has enrolled the first patients in the company’s PerQseal® PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and efficacy of the Vivasure PerQseal Closure Device System.

Key Points: 
  • Vivasure Medical® , a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has enrolled the first patients in the company’s PerQseal® PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and efficacy of the Vivasure PerQseal Closure Device System.
  • The current approach to large-diameter arterial closure is a surgical repair or the use of suture- or collagen-based closure devices.
  • “I’m honored to participate in this study and look forward to gathering additional clinical evidence supporting this innovation’s potential benefits.”
    Vivasure’s pivotal study will enroll up to 171 patients across the U.S. and up to 90 patients in up to eight European investigational sites.
  • The data will support a pre-market approval submission to the U.S. Food and Drug Administration (FDA).

Shockwave Medical Announces U.S. Launch of New Peripheral IVL Catheter

Retrieved on: 
Tuesday, March 14, 2023

SANTA CLARA, Calif., March 14, 2023 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, today announced the full U.S. commercial availability of the Shockwave L6 Peripheral IVL Catheter following clearance by the U.S. Food and Drug Administration (FDA).

Key Points: 
  • SANTA CLARA, Calif., March 14, 2023 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, today announced the full U.S. commercial availability of the Shockwave L6 Peripheral IVL Catheter following clearance by the U.S. Food and Drug Administration (FDA).
  • The Shockwave L6 catheter is purpose-built to modify calcification in otherwise difficult-to-treat lesions in large peripheral vessels, including the iliac and the common femoral arteries.
  • “The characteristics of the new catheter allow physicians to optimize IVL therapy in large peripheral vessels, which represent over 20% of peripheral interventions performed in the U.S. each year.
  • The Shockwave L6 enhances the company’s peripheral IVL portfolio, extending the size offerings of the Shockwave M5+ and Shockwave S4 catheters, to provide physicians with a choice of catheters optimized for the challenges of infrapopliteal, femoropopliteal and iliac arterial territories.

Vivasure Medical Announces FDA IDE Approval to Initiate U.S. Pivotal Study

Retrieved on: 
Monday, March 13, 2023

Vivasure Medical® Limited (“Vivasure” or the “Company”), a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal® Closure Device System.

Key Points: 
  • Vivasure Medical® Limited (“Vivasure” or the “Company”), a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal® Closure Device System.
  • The PATCH pivotal study will enroll up to 188 patients across the U.S. and Europe.
  • The company intends to use the clinical study results to support an FDA pre-market approval submission as well as multinational commercial launch of the PerQseal system for large hole vessel closure.
  • The strategic investment by Haemonetics includes an option to acquire Vivasure Medical upon completion of certain milestones.

Shape Memory Medical Announces First Patient Treated in the EMBO-Post Market Surveillance Registry in Germany

Retrieved on: 
Wednesday, February 22, 2023

Shape Memory Medical Inc., developer of shape memory polymer for peripheral and neurovascular markets, announced the first patient treated in Germany as part of the EMBO-Post Market Surveillance Registry, the Company’s prospective, multicenter, registry study of its IMPEDE and IMPEDE-FX Embolization Plugs when used for peripheral vascular embolization.

Key Points: 
  • Shape Memory Medical Inc., developer of shape memory polymer for peripheral and neurovascular markets, announced the first patient treated in Germany as part of the EMBO-Post Market Surveillance Registry, the Company’s prospective, multicenter, registry study of its IMPEDE and IMPEDE-FX Embolization Plugs when used for peripheral vascular embolization.
  • Ted Ruppel, President and Chief Executive Officer of Shape Memory Medical Inc. said, “We would like to congratulate Professor Richter and the clinical study team at Klinikum Stuttgart for the first EMBO-PMS case in Germany.
  • “We are pleased to participate in this important study and look forward to the follow-up from our treated patients,” said Professor Richter, Principal Investigator for EMBO-Post Market Surveillance German Registry.
  • Shape Memory Medical Inc. is dedicated to developing innovative therapeutic solutions with its proprietary shape memory polymers.

Teleflex Announces Health Canada Approval of MANTA® Vascular Closure Device

Retrieved on: 
Wednesday, May 18, 2022

WAYNE, Pa., May 18, 2022 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today has announced that it received Health Canada approval for the MANTA Vascular Closure Device the first commercially available biomechanical vascular closure device designed specifically for large bore femoral arterial access site closure.1 This approval marks an important milestone in the regulatory plan to expand the availability of the MANTA Device globally and provides access to another uniquely designed device from Teleflex to Canadian clinicians.

Key Points: 
  • WAYNE, Pa., May 18, 2022 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today has announced that it received Health Canada approval for the MANTA Vascular Closure Device the first commercially available biomechanical vascular closure device designed specifically for large bore femoral arterial access site closure.1 This approval marks an important milestone in the regulatory plan to expand the availability of the MANTA Device globally and provides access to another uniquely designed device from Teleflex to Canadian clinicians.
  • Our team has been working diligently to obtain this approval and were confident that Health Canada would recognize the benefits of the MANTA Device, said Scott Holstine, President and General Manager of the Teleflex Interventional Business Unit.
  • Percutaneous vascular closure obtained with the MANTA Device without the use of unplanned endovascular or surgical intervention.
  • A single MANTA Vascular Closure Device was deployed in 99.6% of subjects in IDE trial.

Vivasure Medical Announces Series D Financing to Advance Portfolio of PerQseal Vessel Closure Devices

Retrieved on: 
Tuesday, May 17, 2022

Led by a multi-national strategic corporation, the financing includes an option to buy the Company upon certain milestones.

Key Points: 
  • Led by a multi-national strategic corporation, the financing includes an option to buy the Company upon certain milestones.
  • The financing will support the U.S. and European clinical development and regulatory approval of the Companys portfolio of fully absorbable, patch-based large-bore percutaneous vessel closure devices for transcatheter endovascular and cardiovascular procedures, including PerQseal and PerQseal+ for arterial closure and PerQseal Blue for venous closure.
  • This funding represents an important milestone for our company that will help to further advance our portfolio of novel PerQseal sutureless and fully absorbable vessel closure devices in the U.S. and Europe, said Andrew Glass, chief executive officer of Vivasure Medical.
  • PerQseal, PerQseal+ and PerQseal Blue are not available for sale in the United States.