Aortoiliac occlusive disease

Surmodics Announces 24-Month Data from the SWING Trial Presented at VEITHsymposium

Retrieved on: 
Thursday, November 16, 2023
Health, Clinical Trials, Medical Devices, Safety, Peripheral artery disease, FRANZCR, DCB, Aortoiliac occlusive disease, Auckland City Hospital, Ambient occlusion, PP, CLTI, Freedom, HIV disease progression rates, Classification, ONZM, Pharmaceutical industry, Medical imaging

The SWING Trial is a 35-subject prospective, multi-center, single-arm, feasibility study to evaluate the safety and performance of the Sundance Sirolimus DCB when used to treat occlusive disease of the infrapopliteal arteries.

Key Points: 
  • The SWING Trial is a 35-subject prospective, multi-center, single-arm, feasibility study to evaluate the safety and performance of the Sundance Sirolimus DCB when used to treat occlusive disease of the infrapopliteal arteries.
  • Both primary endpoints of the SWING Trial were achieved.
  • Primary safety endpoint data showed no perioperative deaths or major amputations at 30 days, and just one major re-intervention was reported among the 35 trial subjects.
  • “These results are promising and will inform future trials, which we hope will continue to advance improved treatments for our patients.”

Surmodics Announces SWING Trial 24-Month Data to be Presented at VEITH Symposium on November 15

Retrieved on: 
Tuesday, November 7, 2023
Biotechnology, Medical Devices, Health, Clinical Trials, Medical Supplies, Sale, Aortoiliac occlusive disease, DCB, Cell, Sundance, ISET, Master of Medicine, Freedom, Restenosis, Safety, PHD, Ambient occlusion, PP, MS, Pharmaceutical industry, MBBS, Anesthetic, FRACS

The session will be held on Wednesday, November 15th, at the 50th annual VEITH Symposium in New York, New York.

Key Points: 
  • The session will be held on Wednesday, November 15th, at the 50th annual VEITH Symposium in New York, New York.
  • Professor Varcoe previously presented SWING Trial 12-month data on January 18th at the 35th Annual International Symposium on Endovascular Therapy (ISET) conference.
  • Sirolimus, a potent anti-inflammatory and anti-proliferative compound, has been used successfully in coronary drug-eluting stents.
  • The Sundance Sirolimus Drug-Coated Balloon is not available for sale anywhere in the world, and currently is for investigational use only.

MedAlliance Enrolls First US Patient into its Third FDA IDE Study: SFA SELUTION4SFA

Retrieved on: 
Friday, May 5, 2023
Investigational device exemption, DEB, Freedom, SUCCESS, Aortoiliac occlusive disease, CE marking, ISR, Manatee Memorial Hospital, POBA, De novo, BTK, Patient, SFA, IDE, Coronary artery disease, FDA, PPA, CLTI, Death, Heart, Medical device, Pharmaceutical industry

This study evaluates SELUTION SLR™ in the treatment of occlusive disease of the superficial femoral artery (SFA) and proximal popliteal artery (PPA) and has been designed to support FDA approval.

Key Points: 
  • This study evaluates SELUTION SLR™ in the treatment of occlusive disease of the superficial femoral artery (SFA) and proximal popliteal artery (PPA) and has been designed to support FDA approval.
  • SELUTION SLR is the first and only limus release drug-eluting balloon (DEB) to receive FDA IDE approval for SFA and PPA indications.
  • SELUTION4SFA is being conducted in over 30 centers in the US plus an additional 10 centers worldwide.
  • Over 10,000 units have been used for patient treatments in routine clinical practice or as part of coronary clinical trials.

MedAlliance Enrolls First US Patient into its Third FDA IDE Study: SFA SELUTION4SFA

Retrieved on: 
Thursday, May 4, 2023
Investigational device exemption, DEB, Freedom, SUCCESS, Aortoiliac occlusive disease, CE marking, ISR, Manatee Memorial Hospital, POBA, De novo, BTK, Patient, SFA, IDE, Coronary artery disease, FDA, PPA, CLTI, Death, Heart, Medical device, Pharmaceutical industry

This study evaluates SELUTION SLR™ in the treatment of occlusive disease of the superficial femoral artery (SFA) and proximal popliteal artery (PPA) and has been designed to support FDA approval.

Key Points: 
  • This study evaluates SELUTION SLR™ in the treatment of occlusive disease of the superficial femoral artery (SFA) and proximal popliteal artery (PPA) and has been designed to support FDA approval.
  • SELUTION SLR is the first and only limus release drug-eluting balloon (DEB) to receive FDA IDE approval for SFA and PPA indications.
  • SELUTION4SFA is being conducted in over 30 centers in the US plus an additional 10 centers worldwide.
  • Over 10,000 units have been used for patient treatments in routine clinical practice or as part of coronary clinical trials.

Surmodics Announces SWING Trial 12-Month Data to be Presented at ISET Conference on January 18

Retrieved on: 
Monday, January 16, 2023
Medical Supplies, Health, Medical Devices, Surgery, Clinical Trials, Pharmaceutical, Cardiology, FRANZCR, Cell, MS, Auckland City Hospital, Aortoiliac occlusive disease, Safety, SCB Park Plaza, ISET, PHD, ONZM, Master of Medicine, Sale, DCB, Restenosis, International Symposium on Endovascular Therapy, Pharmaceutical industry, FRACS, Bachelor of Medicine, Bachelor of Surgery, MBBS, Anesthetic

The session will be held on Wednesday, January 18, at the 35th annual International Symposium on Endovascular Therapy (ISET) conference in Miami, Florida.

Key Points: 
  • The session will be held on Wednesday, January 18, at the 35th annual International Symposium on Endovascular Therapy (ISET) conference in Miami, Florida.
  • Professor Varcoe will also discuss the differentiated capabilities of the Surmodics crystalline drug release platform for sirolimus-coated balloons (SCBs) in connection with 12-month data from the SWING trial.
  • Professor Varcoe recently presented SWING Trial 12-month data on Nov. 16 at the 49th Annual Symposium on Vascular and Endovascular Issues (VEITHsymposium).
  • The Sundance Sirolimus Drug-Coated Balloon is not available for sale anywhere in the world, and currently is for investigational use only.

MedAlliance SELUTION SLR is the first DEB to receive coronary de novo IDE approval, its fourth FDA IDE DEB Approval

Retrieved on: 
Wednesday, January 11, 2023
DEB, BTK, Peripheral artery disease, ISR, Cardiology, DES, IDE, Passiflora foetida, Risk, Aortoiliac occlusive disease, Research, Coronary artery disease, Patient, CE marking, Safety, SFA, PTCA, Georgetown University, Diabetes, Pharmaceutical industry

Enrollment of the SELUTION SLR coronary de novo study will begin in the US within the next few months.

Key Points: 
  • Enrollment of the SELUTION SLR coronary de novo study will begin in the US within the next few months.
  • This will complement the substantial experience that the company has already gained with the SELUTION DeNOVO trial in Europe (ClinicalTrials.gov Identifier: NCT04859985).
  • The study is powered to demonstrate superiority of SELUTION SLR drug-eluting balloon (DEB) over DES in coronary de novo artery disease.
  • "Treatment of de novo coronary arteries with drug-eluting balloons is a breakthrough in revascularization of coronary artery disease.

MedAlliance SELUTION SLR is the first DEB to receive coronary de novo IDE approval, its fourth FDA IDE DEB Approval

Retrieved on: 
Tuesday, January 10, 2023
DEB, BTK, Peripheral artery disease, ISR, Cardiology, DES, IDE, Passiflora foetida, Risk, Aortoiliac occlusive disease, Research, Coronary artery disease, Patient, CE marking, Safety, SFA, PTCA, Georgetown University, Diabetes, Pharmaceutical industry

Enrollment of the SELUTION SLR coronary de novo study will begin in the US within the next few months.

Key Points: 
  • Enrollment of the SELUTION SLR coronary de novo study will begin in the US within the next few months.
  • This will complement the substantial experience that the company has already gained with the SELUTION DeNOVO trial in Europe (ClinicalTrials.gov Identifier: NCT04859985).
  • The study is powered to demonstrate superiority of SELUTION SLR drug-eluting balloon (DEB) over DES in coronary de novo artery disease.
  • "Treatment of de novo coronary arteries with drug-eluting balloons is a breakthrough in revascularization of coronary artery disease.

Surmodics Announces 12-Month Data from the SWING Trial Presented at VEITHsymposium

Retrieved on: 
Thursday, November 17, 2022
Medical Supplies, Health, Medical Devices, Surgery, Clinical Trials, Pharmaceutical, Cardiology, MALE, Restenosis, Sale, Ambient occlusion, Peripheral artery disease, Cell, DCB, Freedom, PHD, PP, FRANZCR, MS, Safety, HIV disease progression rates, IVD, Disease, Master of Medicine, Annual report, ONZM, Growth, Classification, MD, Aortoiliac occlusive disease, Pharmaceutical industry, Medical imaging, FRACS, MBBS, Bachelor of Medicine, Bachelor of Surgery

The primary efficacy endpoint is the rate of late lumen loss at 6 months, as assessed by quantitative vascular angiography.

Key Points: 
  • The primary efficacy endpoint is the rate of late lumen loss at 6 months, as assessed by quantitative vascular angiography.
  • Both primary endpoints of the SWING Trial were achieved.
  • Primary safety endpoint data showed no perioperative deaths or major amputations at 30 days, and just one major re-intervention was reported among the 35 trial subjects.
  • The SWING Trial demonstrates that the Sundance Sirolimus DCB has tremendous promise and warrants evaluation in a large-scale pivotal trial.

Surmodics Announces SWING Trial 12-Month Data to be Presented at VEITHsymposium on November 16

Retrieved on: 
Friday, November 11, 2022
Medical Devices, Health, Surgery, Clinical Trials, General Health, Pharmaceutical, Aortoiliac occlusive disease, Sale, Company, Annual report, NASDAQ, Disease, Auckland City Hospital, Technology, Cell, DCB, SEC, Safety, Investor, 3rd Floor, Forward-looking statement, MS, Restenosis, Master of Medicine, FRANZCR, AMP, Growth, Amputation, PHD, ONZM, Pharmaceutical industry, Bachelor of Medicine, Bachelor of Surgery, FRACS, Anesthetic, MBBS

The session will be held on Wednesday, November 16, at the 49th Annual Symposium on Vascular and Endovascular Issues (VEITHsymposium) in New York City.

Key Points: 
  • The session will be held on Wednesday, November 16, at the 49th Annual Symposium on Vascular and Endovascular Issues (VEITHsymposium) in New York City.
  • Professor Andrew Holden, MBChB, FRANZCR, EBIR, ONZM, Director of Northern Region Interventional Radiology Service at Auckland City Hospital in Auckland, New Zealand, is also a co-lead investigator for the SWING Trial.
  • Professor Varcoe recently presented SWING Trial 6-month data on October 11 as part of the Amputation Prevention Symposium (AMP) in Lugano, Switzerland.
  • Surmodics is a leading provider of surface modification technologies for intravascular medical devices and chemical components for in vitro diagnostic immunoassay tests and microarrays.

6-Month Data from the Surmodics SWING BTK First-in-Human Trial Presented at AMP Europe

Retrieved on: 
Tuesday, October 11, 2022
Health, Medical Devices, Surgery, General Health, Clinical Trials, Pharmaceutical, Cardiology, Disease, Sale, SEC, LLL, MS, Population, CLI, Growth, Investor, FIH, PHD, Annual report, NASDAQ, DCB, Cell, Amputation, Restenosis, Technology, ONZM, Company, IVD, MD, RVD, Safety, Diabetes, AMP, FRANZCR, Master of Medicine, Forward-looking statement, Aortoiliac occlusive disease, Medical device, Pharmaceutical industry, FRACS, MBBS, Bachelor of Medicine, Bachelor of Surgery

The studys primary safety endpoint data showed no perioperative deaths or major amputations at 30 days and just one major re-intervention was reported among the 35 trial subjects.

Key Points: 
  • The studys primary safety endpoint data showed no perioperative deaths or major amputations at 30 days and just one major re-intervention was reported among the 35 trial subjects.
  • The Sundance Sirolimus Drug-Coated Balloon is not available for sale anywhere in the world, and currently is for investigational use only.
  • Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements.
  • The content of Surmodics website is not part of this press release or part of any filings that the company makes with the SEC.