Popliteal artery

Surmodics Announces TRANSCEND Trial 36-Month Data Presented at 50th Annual VEITH Symposium

Retrieved on: 
Thursday, November 16, 2023

Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that 36-month data from its TRANSCEND clinical trial was presented by Dr. Peter A. Schneider at the 50th Annual VEITH Symposium in New York, New York.

Key Points: 
  • Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that 36-month data from its TRANSCEND clinical trial was presented by Dr. Peter A. Schneider at the 50th Annual VEITH Symposium in New York, New York.
  • The TRANSCEND trial is a prospective, multi-center, single-blind, randomized, controlled trial to assess the safety and efficacy of the SurVeil™ drug coated balloon (DCB) versus the IN.PACT® Admiral® DCB for treatment of superficial femoral and proximal popliteal artery lesions.
  • The primary efficacy endpoint is 12-month primary patency, defined as freedom from binary restenosis or clinically driven target lesion revascularization (CD-TLR).
  • “The TRANSCEND 36-Month data continues to demonstrate safe and effective performance of the SurVeil DCB.

Excellent 12-Month Results from SELUTION SFA Trial Presented at JET

Retrieved on: 
Wednesday, May 31, 2023

GENEVA, May 31, 2023 /PRNewswire/ -- 12-month results from the SELUTION SFA trial have been presented at the Japan Endovascular Treatment (JET) Conference in Tokyo.

Key Points: 
  • GENEVA, May 31, 2023 /PRNewswire/ -- 12-month results from the SELUTION SFA trial have been presented at the Japan Endovascular Treatment (JET) Conference in Tokyo.
  • The prospective, multicenter single arm trial has involved 134 patients treated across 13 sites in Japan.
  • The primary endpoint of 12-month primary patency of the target lesion was achieved in 87.9% of patients.
  • This complements the substantial experience that the company has gained with the SELUTION DeNovo and SUCCESS trials in Europe.

Cardiovascular Systems, Inc. Enrolls First Patient in Japan for Kaizen Clinical Study

Retrieved on: 
Wednesday, January 11, 2023

The first KAIZEN patient was enrolled by Tatsuya Nakama, M.D., Vice Director, Department of Cardiology, Tokyo Bay Urayasu Ichikawa Medical Center.

Key Points: 
  • The first KAIZEN patient was enrolled by Tatsuya Nakama, M.D., Vice Director, Department of Cardiology, Tokyo Bay Urayasu Ichikawa Medical Center.
  • Dr. Nakama said, “I felt that the Diamondback 360© Peripheral OAS offered both effective treatment and ease of use.
  • OAS has demonstrated safety and efficacy in the U.S. population and this study is designed to confirm this in Japan.
  • I believe the Diamondback 360© Peripheral OAS has great potential for this underserved patient population, and I look forward to evaluating it in Japan.

CHOCOLATE TOUCH®, NEXT-GENERATION DRUG-COATED ANGIOPLASTY BALLOON FOR THE TREATMENT OF PERIPHERAL ARTERIAL DISEASE RECEIVES FDA APPROVAL

Retrieved on: 
Friday, November 11, 2022

Mortality rates for Chocolate Touch using KM estimates at 3 years were 6.7% for the Chocolate Touch and 11.1% for the Lutonix DCB.

Key Points: 
  • Mortality rates for Chocolate Touch using KM estimates at 3 years were 6.7% for the Chocolate Touch and 11.1% for the Lutonix DCB.
  • The Chocolate Touch drug-coated balloon is the world's first and only balloon catheter that integrates therapeutic agent delivery with the next generation angioplasty platform, for the treatment of peripheral arterial disease.
  • With the goal of providing patients suffering from peripheral arterial disease with an alternative treatment to traditional drug-coated balloon angioplasty.
  • Its first technology, the Chocolate Touch is a next generation drug-coated balloon and the world's first balloon catheter that integrates therapeutic agent delivery with the next generation angioplasty platform, for the treatment of peripheral arterial disease.

CHOCOLATE TOUCH®, NEXT-GENERATION DRUG-COATED ANGIOPLASTY BALLOON FOR THE TREATMENT OF PERIPHERAL ARTERIAL DISEASE RECEIVES FDA APPROVAL

Retrieved on: 
Friday, November 11, 2022

Mortality rates for Chocolate Touch using KM estimates at 3 years were 6.7% for the Chocolate Touch and 11.1% for the Lutonix DCB.

Key Points: 
  • Mortality rates for Chocolate Touch using KM estimates at 3 years were 6.7% for the Chocolate Touch and 11.1% for the Lutonix DCB.
  • The Chocolate Touch drug-coated balloon is the world's first and only balloon catheter that integrates therapeutic agent delivery with the next generation angioplasty platform, for the treatment of peripheral arterial disease.
  • With the goal of providing patients suffering from peripheral arterial disease with an alternative treatment to traditional drug-coated balloon angioplasty.
  • Its first technology, the Chocolate Touch is a next generation drug-coated balloon and the world's first balloon catheter that integrates therapeutic agent delivery with the next generation angioplasty platform, for the treatment of peripheral arterial disease.

24-Month Data from Surmodics’ TRANSCEND Trial Presented at VIVA 2022 Conference

Retrieved on: 
Wednesday, November 2, 2022

Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that 24-month data from its TRANSCEND clinical trial has been presented at the Vascular InterVentional Advances (VIVA) annual conference in Las Vegas.

Key Points: 
  • Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that 24-month data from its TRANSCEND clinical trial has been presented at the Vascular InterVentional Advances (VIVA) annual conference in Las Vegas.
  • Subjects in the TRANSCEND Trial will be followed for 60 months.
  • Data presented Tuesday by TRANSCEND trial principal investigator Dr. Kenneth Rosenfield, M.D., demonstrated comparable, sustained clinical outcomes between the SurVeil DCB and IN.PACT Admiral DCB cohorts through 24 months.
  • The TRANSCEND trials two-year data showed a primary patency rate of 70.8% for SurVeil DCB subjects vs. 70.4% for IN.PACT Admiral.

Surmodics Announces TRANSCEND Trial 24-Month Data to be Presented at VIVA 2022

Retrieved on: 
Wednesday, October 26, 2022

The primary efficacy endpoint is 12-month primary patency, defined as freedom from binary restenosis or clinically driven target lesion revascularization (CD-TLR).

Key Points: 
  • The primary efficacy endpoint is 12-month primary patency, defined as freedom from binary restenosis or clinically driven target lesion revascularization (CD-TLR).
  • The primary safety endpoint is freedom from device or procedure related death within 30 days and above-ankle amputation or CD-TVR within 12 months.
  • In February 2018, Surmodics entered into an agreement with Abbott (NYSE: ABT) that provided Abbott with exclusive worldwide commercialization rights for the SurVeil DCB.
  • Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements.

The Amputee Coalition’s National Conference Welcomes over 650 Attendees in the Limb Loss and Limb Difference Community

Retrieved on: 
Wednesday, August 10, 2022

The Amputee Coalition is the only national nonprofit serving those living with limb loss or limb difference.

Key Points: 
  • The Amputee Coalition is the only national nonprofit serving those living with limb loss or limb difference.
  • The Amputee Coalition empowers people affected by limb loss and limb difference to achieve their full potential through support, education, advocacy, and prevention.
  • The Amputee Coalition is the only national nonprofit that serves all individuals who experience limb loss or limb difference.
  • We work to provide vital resources to people with limb loss and limb difference, as well as their families and caregivers.

Pounce™ Thrombectomy System First-in-Human Data Show 100 Percent Technical Success in Early Cases

Retrieved on: 
Wednesday, April 27, 2022

Technical success was defined as the removal of clot to restore blood flow without the use of an additional adjunct thrombectomy device.

Key Points: 
  • Technical success was defined as the removal of clot to restore blood flow without the use of an additional adjunct thrombectomy device.
  • The Pounce Thrombectomy System demonstrated technical success in these early clinical cases, showing an ability to quickly deal with a wide range of clot from soft to organized, including emboli in the peripheral arterial vasculature, said Ansel.
  • The Pounce Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.
  • The Pounce Thrombectomy System has the potential to revolutionize the treatment algorithm for arterial thrombectomy, said Gary Maharaj, Surmodics CEO.

Boston Scientific Eluvia™ Drug-Eluting Vascular Stent System Exhibits Superiority Compared to Bare Metal Stents

Retrieved on: 
Wednesday, October 6, 2021

LAS VEGAS and MARLBOROUGH, Mass., Oct. 6, 2021 /PRNewswire/ -- Today, Boston Scientific Corporation (NYSE: BSX) announced positive data for the Eluvia Drug-Eluting Vascular Stent System (Eluvia stent) during a late-breaking clinical trial presentation at the Vascular InterVentional Advances (VIVA) meeting in Las Vegas.

Key Points: 
  • LAS VEGAS and MARLBOROUGH, Mass., Oct. 6, 2021 /PRNewswire/ -- Today, Boston Scientific Corporation (NYSE: BSX) announced positive data for the Eluvia Drug-Eluting Vascular Stent System (Eluvia stent) during a late-breaking clinical trial presentation at the Vascular InterVentional Advances (VIVA) meeting in Las Vegas.
  • Data presented included one-year results from the EMINENT trial, which demonstrated superiority of the Eluvia stent compared to self-expanding bare metal stents (BMS) for the treatment of patients with peripheral artery disease (PAD) and superficial femoral artery (SFA) or popliteal artery (PPA) lesions up to 210 mm in length.
  • The study enrolled 775 patients, making it the largest randomized trial of a drug-eluting stent for the treatment of PAD to date.
  • Further, there was no significant difference in major adverse events or all-cause mortality rates between patients treated with the Eluvia stent and those treated with BMS through one year.