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Reflow Medical Reports Six-Month Results from DEEPER CORONARY Study of Spur® Elute Stent

Business

Reflow Medical Reports Six-Month Results from DEEPER CORONARY Study of Spur® Elute Stent
Business

Business

Reflow Medical Reports Six-Month Results from DEEPER CORONARY Study of Spur® Elute Stent

2026-05-21 03:02 Last Updated At:03:31

SAN CLEMENTE, Calif.--(BUSINESS WIRE)--May 20, 2026--

Reflow Medical, Inc., a leading developer of innovative devices for treating complex cardiovascular disease, announces the presentation of the first six-month clinical results from the DEEPER CORONARY study at EuroPCR 2026 in Paris, France. The study evaluates the investigational coronary Spur ® Elute Sirolimus-Eluting Retrievable Stent System for coronary in-stent restenosis (ISR).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260520334491/en/

The data was presented by Scott Harding, MD, Director of the Cardiology Research Group at Wellington Hospital, Wellington, New Zealand, and principal investigator for the DEEPER CORONARY trial.

DEEPER CORONARY is a first-in-human pilot study designed to evaluate the short-term safety of the investigational coronary Spur Elute System as a primary treatment for coronary ISR. Six-month study results showed 100% freedom from MACE and 100% freedom from all-cause mortality among nine treated subjects. Improvement in CCS angina class was observed in all patients, with a median improvement of three classes.

“The six-month data from DEEPER CORONARY provide encouraging acute and mid-term safety and efficacy results utilizing the investigational Spur Elute system,” said Scott Harding, MD. “These early findings support the continued clinical evaluation of this retrievable, sirolimus-eluting stent approach in ISR and further potential for CAD treatment.”

The coronary Spur Elute Stent System is the first and only retrievable self-expanding stent with radially expandable spikes, combined with an integrated balloon, both of which are drug-coated with a sirolimus drug formulation unique to Reflow Medical. Known as Retrievable Scaffold Therapy (RST), the Spur Elute spikes create channels to increase uptake of the antiproliferative drug into the vessel wall, while the temporary stent supports the arterial lumen. Together, these mechanisms are intended to maximize luminal diameter and reduce the risk of restenosis. The system is then fully removed without leaving a permanent metallic implant behind.

“These encouraging results are an important milestone for our coronary program designed to benefit patients suffering from coronary disease,” said Isa Rizk, CEO and Co-Founder of Reflow Medical. “We thank Professor Harding, the investigators, and our partners for advancing this first-in-human study and the continued evaluation of the coronary Spur Elute.”

The coronary Spur Elute Sirolimus-Eluting Retrievable Stent System is an investigational device only.

About Reflow Medical, Inc.

Reflow Medical is a global company that partners with leading physicians to develop innovative technologies addressing unmet clinical needs in the endovascular treatment of complex cardiovascular disease. The company’s portfolio includes coronary and peripheral microcatheters, crossing catheters, and its proprietary Retrievable Scaffold Therapy (RST) platform. The coronary Cora Catheters™ line is FDA approved. The peripheral product line includes Wingman™, Spex ®, Spex LP, and Spur ®, which have FDA clearance and CE Mark registration. Reflow Medical is headquartered in San Clemente, California.

Reflow Medical Reports Six-Month Results from DEEPER CORONARY Study of Spur® Elute Stent

Reflow Medical Reports Six-Month Results from DEEPER CORONARY Study of Spur® Elute Stent

ZURICH (AP) — Ryan Leonard scored the decisive penalty for the United States in a 4-3 shootout win over Germany at the ice hockey world championship on Wednesday.

Tommy Novak tied it at 3-3 for the U.S. with 5:47 left in regulation after Germany goaltender Philipp Grubauer was unable to hold onto the puck.

The defending champion Americans recovered from a 6-2 loss to Finland on Monday for their second win from four games and have five points in Group A in Zurich.

The Germans earned their first point.

Isaac Howard and Max Sasson also scored for the U.S. and goaltender Devin Cooley allowed one goal in the shootout.

Germany took an early lead when captain Moritz Seider scored one minute into the game. Howard tied it at 1-1 before the end of the first and Sasson's goal put the Americans ahead early in the second period.

Still in the second, the Germans rallied with Frederik Tiffels' tying goal and Marc Michaelis' go-ahead tally less than three minutes later.

Florida Panthers forward Matthew Tkachuk, who arrived at Zurich on Tuesday, played his first career game at the worlds. The two-time Stanley Cup winner and Olympic champion failed to convert his penalty shot.

The U.S. plays Latvia on Saturday.

Switzerland routed Austria 9-0 to keep a perfect record.

Theo Rochette, Nico Hischier and Damien Riat each scored two goals as the Swiss won their fourth straight game to lead Group A in Zurich with 12 points.

Sven Andrighetto had three assists and Leonardo Genoni stopped 20 shots.

After finishing runner-up the previous two years, host Switzerland hopes for more in front of the home supporters.

Austria remains on nine points after its first loss.

In Group B in Fribourg, Czechia rallied late to edge winless Italy 3-1.

Nicholas Saracino put Italy in front 1-0 in the second period — for only the second goal by Italy at the worlds.

Early in the third, Marek Alscher tied it at 1-1 and Jakub Flek scored the eventual winner with 8:55 left. Dominik Kubalík added an empty-netter.

The Czechs, atop their group with 10 points, outshot Italy 58-15.

In another game in Fribourg, Raymond Lucas and Jacob de la Rose each scored two goals in Sweden's 6-0 win over Slovenia. Robert Hagg and Mattias Ekholm also scored.

AP sports: https://apnews.com/sports

Sweden's Carl Grundstrom, left, vies for the puck against Slovenia's Marcel Mahkovec, right, during the 2026 IIHF Men's Ice Hockey World Championship preliminary round group B game between Sweden and Slovenia, in Fribourg, Switzerland, Wednesday, May 20, 2026. (Cyril Zingaro/Keystone via AP)

Sweden's Carl Grundstrom, left, vies for the puck against Slovenia's Marcel Mahkovec, right, during the 2026 IIHF Men's Ice Hockey World Championship preliminary round group B game between Sweden and Slovenia, in Fribourg, Switzerland, Wednesday, May 20, 2026. (Cyril Zingaro/Keystone via AP)

Germany's Marc Michaelis, right, celebrates with teammates after scoring their third goal during a Group A preliminary round game between the United States and Germany at the men's ice hockey world championship in Zurich, Switzerland, Wednesday, May 20, 2026. (Andreas Becker/Keystone via AP)

Germany's Marc Michaelis, right, celebrates with teammates after scoring their third goal during a Group A preliminary round game between the United States and Germany at the men's ice hockey world championship in Zurich, Switzerland, Wednesday, May 20, 2026. (Andreas Becker/Keystone via AP)

United States Alex Steeves falls in the crease between Germany's goaltender Philipp Grubauer, left, and Leon Gawanke during a Group A preliminary round game between the United States and Germany at the men's ice hockey world championship in Zurich, Switzerland, Wednesday, May 20, 2026. (Andreas Becker/Keystone via AP)

United States Alex Steeves falls in the crease between Germany's goaltender Philipp Grubauer, left, and Leon Gawanke during a Group A preliminary round game between the United States and Germany at the men's ice hockey world championship in Zurich, Switzerland, Wednesday, May 20, 2026. (Andreas Becker/Keystone via AP)

United States' Ryan Leonard, left, scores the decisive goal in the penalty shootout during a Group A preliminary round game between the USA and Germany at the men's ice hockey world championship in Zurich, Switzerland, Wednesday, May 20, 2026. (Andreas Becker/Keystone via AP)

United States' Ryan Leonard, left, scores the decisive goal in the penalty shootout during a Group A preliminary round game between the USA and Germany at the men's ice hockey world championship in Zurich, Switzerland, Wednesday, May 20, 2026. (Andreas Becker/Keystone via AP)

United States' Ryan Leonard celebrates after scoring the decisive goal in the penalty shootout during a Group A preliminary round game between the USA and Germany at the men's ice hockey world championship in Zurich, Switzerland, Wednesday, May 20, 2026. (Andreas Becker/Keystone via AP)

United States' Ryan Leonard celebrates after scoring the decisive goal in the penalty shootout during a Group A preliminary round game between the USA and Germany at the men's ice hockey world championship in Zurich, Switzerland, Wednesday, May 20, 2026. (Andreas Becker/Keystone via AP)

Czechia's Marek Alscher, center, celebrates with Matej Blumel, right, and Jiri Tichacek, left, after scoring during a Group B preliminary round game between the Czech Republic and Italy in Fribourg, Switzerland, Wednesday, May 20, 2026. (Cyril Zingaro/Keystone via AP)

Czechia's Marek Alscher, center, celebrates with Matej Blumel, right, and Jiri Tichacek, left, after scoring during a Group B preliminary round game between the Czech Republic and Italy in Fribourg, Switzerland, Wednesday, May 20, 2026. (Cyril Zingaro/Keystone via AP)

Switzerland's players celebrate after scoring during the 2026 IIHF Men's Ice Hockey World Championship preliminary round group A game between Austria and Switzerland, in Zurich, Switzerland, Wednesday, May 20, 2026. (Andreas Becker/Keystone via AP)

Switzerland's players celebrate after scoring during the 2026 IIHF Men's Ice Hockey World Championship preliminary round group A game between Austria and Switzerland, in Zurich, Switzerland, Wednesday, May 20, 2026. (Andreas Becker/Keystone via AP)

Switzerland's Theo Rochette, behind left,and Switzerland's Damien Riat, center, celebrate the fourth goal in front of Austria's Ramon Schnetzer, left, and Austria's goaltender David Kickert, right, during the 2026 IIHF Men's Ice Hockey World Championship preliminary round group A game between Austria and Switzerland, in Zurich, Switzerland, Wednesday, May 20, 2026. (Claudio Thoma/Keystone via AP)

Switzerland's Theo Rochette, behind left,and Switzerland's Damien Riat, center, celebrate the fourth goal in front of Austria's Ramon Schnetzer, left, and Austria's goaltender David Kickert, right, during the 2026 IIHF Men's Ice Hockey World Championship preliminary round group A game between Austria and Switzerland, in Zurich, Switzerland, Wednesday, May 20, 2026. (Claudio Thoma/Keystone via AP)

Switzerland's Theo Rochette, right in white, scores the teams first goal against, from left, Austria's Ian Scherzer, Austria's Ramon Schnetzer and Austria's goaltender David Kickert during the 2026 IIHF Men's Ice Hockey World Championship preliminary round group A game between Austria and Switzerland, in Zurich, Switzerland, Wednesday, May 20, 2026. (Claudio Thoma/Keystone via AP)

Switzerland's Theo Rochette, right in white, scores the teams first goal against, from left, Austria's Ian Scherzer, Austria's Ramon Schnetzer and Austria's goaltender David Kickert during the 2026 IIHF Men's Ice Hockey World Championship preliminary round group A game between Austria and Switzerland, in Zurich, Switzerland, Wednesday, May 20, 2026. (Claudio Thoma/Keystone via AP)

Switzerland's Nico Hischier, right, scores the fifth goal to Austria's goaltender David Kickert, left, during the 2026 IIHF Men's Ice Hockey World Championship preliminary round group A game between Austria and Switzerland, in Zurich, Switzerland, Wednesday, May 20, 2026. (Claudio Thoma/Keystone via AP)

Switzerland's Nico Hischier, right, scores the fifth goal to Austria's goaltender David Kickert, left, during the 2026 IIHF Men's Ice Hockey World Championship preliminary round group A game between Austria and Switzerland, in Zurich, Switzerland, Wednesday, May 20, 2026. (Claudio Thoma/Keystone via AP)

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