DEEPER OUS Trial Evaluating Reflow Medical’s Bare Temporary Spur Stent System Shows Positive Results at Six Months

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Reflow Medical, Inc. announced the six-month results of the DEEPER OUS clinical trial (NCT03807531) evaluating the safety and efficacy of the Bare Temporary Spur Stent System.

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Business Wire, Inc.Business Wire, Inc.
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Tuesday, June 13, 2023
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Health, Clinical Trials, Cardiology, Medical Devices, Medicine, Freedom, Senior, Calcification, Multimedia, Federal, Bare, MD, Patient, MALE, LINC, Research, Safety, POD, FESC, Angiology, Pharmaceutical industry, Telescopic sight, Medical device
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UNITED STATES, NORTH AMERICA, CALIFORNIA, GERMANY
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REFLOW MEDICAL, REFLOW MEDICAL, INC.
Summary
Key Points: 
  • Reflow Medical, Inc. announced the six-month results of the DEEPER OUS clinical trial (NCT03807531) evaluating the safety and efficacy of the Bare Temporary Spur Stent System.
  • In 38 patients with a total of 40 lesions treated with the Bare Temporary Spur Stent System, results demonstrated:
    a trend toward improved six-month patency in subjects without vessel recoil.
  • Prof. Zeller discussed these and other results in his presentation, “DEEPER OUS trial - Vessel Recoil Sub-study: Initial Insights.”
    The Bare Temporary Spur Stent System is designed to deliver a temporary stent with integrated radial spikes to the peripheral vasculature via a sheathed delivery system, for stent-like results while leaving nothing behind.
  • “We’re looking forward to continuing to see great results from the study.”
    The Bare Temporary Spur Stent System is for investigational use only.


Reflow Medical, Inc. announced the six-month results of the DEEPER OUS clinical trial (NCT03807531) evaluating the safety and efficacy of the Bare Temporary Spur Stent System. Results were presented at the annual Leipzig International Course (LINC) in Leipzig, Germany.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230612021725/en/

Temporary Spur Stent System - Caution: Investigational device; limited by Federal law to investigational use only.(Graphic: Business Wire)

Temporary Spur Stent System - Caution: Investigational device; limited by Federal law to investigational use only.(Graphic: Business Wire)

Michael Lichtenberg, MD, FESC, Chief Medical Officer and Director of the Angiology and Vascular Center in Arnsberg, Germany, reported that the study of the Bare Temporary Spur Stent System used in conjunction with a commercially available paclitaxel-coated balloon met:

  • the primary effectiveness endpoint with an 86% primary patency rate at six months, and
  • the primary safety endpoint, i.e., freedom from target limb major adverse limb event (MALE) and all-cause perioperative death (POD) at 30 days, in 100% of subjects.

The results of a sub-study evaluating acute vessel recoil were presented by Professor Thomas Zeller, MD, Chief of the Department of Angiology at University Heart Center Freiburg-Bad Krozingen. In 38 patients with a total of 40 lesions treated with the Bare Temporary Spur Stent System, results demonstrated:

  • an impressive reduction in vessel recoil of more than 50%, 42.5% compared to previously reported rates of 97% with percutaneous transluminal angioplasty (PTA), and
  • a trend toward improved six-month patency in subjects without vessel recoil.

Prof. Zeller discussed these and other results in his presentation, “DEEPER OUS trial - Vessel Recoil Sub-study: Initial Insights.”

The Bare Temporary Spur Stent System is designed to deliver a temporary stent with integrated radial spikes to the peripheral vasculature via a sheathed delivery system, for stent-like results while leaving nothing behind.

“It’s gratifying to see the improvement in our patients six months after treatment with the Spur Stent System,” said Dr. Lichtenberg. “We observed improvements in their Rutherford class scores, and fewer than 8% required revascularization during the six-month period.”

According to Prof. Zeller, the sub-study results also showed that “calcification did not appear to have an effect on vessel patency or vessel recoil, suggesting that the Bare Temporary Spur Stent System may modify calcification, decrease recoil and enhance drug uptake.”

“We’re very grateful to Dr. Lichtenberg, Prof. Zeller, and the other investigators and teams involved in the trial, as well as to the patients for their participation,” said Teo Jimenez, Senior Vice President for Research and Development at Reflow Medical. “We’re looking forward to continuing to see great results from the study.”

The Bare Temporary Spur Stent System is for investigational use only. Follow-up to five years is ongoing.

About Reflow Medical, Inc.

Reflow Medical, Inc., established in 2011, is a private company focused on empowering physicians through the design and development of innovative and effective technologies for treating cardiovascular disease.

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