Cardiovascular Today—May 28, 2026

This week’s Cardiovascular update highlights regulatory clearances, long-term device data, imaging advances, pulmonary embolism trial progress, and ongoing FDA safety scrutiny across cardiovascular interventions.

In Today’s Newsletter

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💉 Reflow Medical reports six-month DEEPER CORONARY results [1] [France • 21 May 2026]

https://cardiovascularnews.com/europcr-2026-reflow-medical-reports-encouraging-six-month-results-from-deeper-coronary-study/
Context: DEEPER CORONARY is a first-in-human pilot of investigational coronary Spur Elute for coronary in-stent restenosis, presented at EuroPCR 2026.
Key point: Reflow Medical reported 100% freedom from MACE and all-cause mortality at six months in nine treated subjects.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Acist Pro receives US FDA clearance [2] [US • 20 May 2026]

https://cardiovascularnews.com/us-fda-clears-acist-medical-systems-next-generation-contrast-management-solution/
Context: Acist Pro (Acist Medical Systems, Bracco) is a variable-rate contrast management system for image-guided cardiovascular procedures.
Key point: The company announced US FDA clearance after prior Japan introduction and CE mark approval in Europe.
Implication: May expand screening, initiation, and follow-up at scale.

🖥️ Philips launches SmartIQ coronary imaging technology [3] [France • 20 May 2026]

https://cardiovascularnews.com/philips-introduces-smartiq-coronary-imaging-technology/
Context: SmartIQ is a Philips coronary imaging technology for Azurion, showcased at EuroPCR 2026.
Key point: Philips said a blinded pilot study favored SmartIQ for image quality while maintaining or lowering radiation and contrast dose.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🫀 DynamX bioadaptor shows lower four-year event rates [4] [France • 20 May 2026]

https://cardiovascularnews.com/europcr-2026-dynamx-bioadaptor-demonstrates-significantly-lower-event-rates-than-drug-eluting-stent/
Context: Elixir Medical reported four-year BIOADAPTOR RCT data in 445 patients across Japan, Europe, and New Zealand.
Key point: DynamX had a lower target lesion failure rate than Resolute Onyx DES, 2.8% vs 7.8%, with p=0.02.
Implication: May influence prescriber choice and payer reviews pending full data.

🫁 Jupiter Endovascular reports positive SPIRARE II data [5] [France • 21 May 2026]

https://cardiovascularnews.com/europcr-2026-jupiter-endovascular-announces-positive-results-from-spirare-ii-pivotal-trial/
Context: SPIRARE II evaluated Vertex pulmonary embolectomy in 123 acute intermediate-risk PE patients at 19 sites in Europe and the USA.
Key point: Jupiter said the trial met both primary endpoints, including RV/LV ratio reduction and a 2.4% MAE rate.
Implication: May influence prescriber choice and payer reviews pending full data.

🦇 BATMAN technique reduces LVOT obstruction risk in TMVR [6] [US • 22 May 2026]

https://cardiovascularbusiness.com/topics/clinical/interventional-cardiology/batman-rescue-tmvr-technique-helps-cardiologists-reduce-risk-lvot-obstruction
Context: The JACC: Cardiovascular Interventions analysis included 83 high-risk TMVR patients treated from 2023 to 2026.
Key point: BATMAN was associated with 98.8% technical success and 95.1% TMVR free of LVOT obstruction and procedural death.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

⚠️ FDA warns on Johnson & Johnson Impella controllers [7] [US • 21 May 2026]

https://cardiovascularbusiness.com/topics/clinical/interventional-cardiology/fda-warns-public-about-johnson-johnson-heart-pump-controllers-after-patient-death
Context: The FDA warned about Automated Impella Controllers used with left ventricular Impella devices.
Key point: A software-related restart risk was linked to two serious injuries and one death; no device return was required.
Implication: Introduces competition that may affect pricing and formulary access.

🚨 FDA confirms Class I recall for Relay Pro thoracic stent grafts [8] [US • 26 May 2026]

https://cardiovascularbusiness.com/topics/clinical/vascular-endovascular/fda-confirms-class-i-recall-vascular-device-used-cardiologists-and-surgeons
Context: The FDA classified an issue with certain Terumo Aortic Relay Pro Thoracic Stent Grafts as a Class I recall.
Key point: The issue involves failure to unclasp from the delivery system and was linked to three patient deaths.
Implication: Introduces competition that may affect pricing and formulary access.

Why it matters

EuroPCR 2026 generated multiple device readouts across coronary ISR, PCI implants, PE thrombectomy, and imaging.
Several updates focus on reducing procedural risk, including contrast exposure, radiation dose, LVOT obstruction, and PE hemodynamics.
FDA safety actions show continued post-market scrutiny of cardiovascular support and vascular repair devices.
Small early datasets, single-arm studies, and observational analyses need careful interpretation before broad clinical adoption.

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FAQ

What is Reflow Medical’s Spur Elute being studied for?

Spur Elute is an investigational retrievable, sirolimus-eluting coronary stent system studied in DEEPER CORONARY for in-stent restenosis. [1]

What did Acist Medical Systems receive from the FDA?

Acist Medical Systems received US FDA clearance for Acist Pro, a next-generation contrast management system for cardiovascular procedures. [2]

What is Philips SmartIQ intended to improve?

Philips SmartIQ is intended to improve coronary image quality while optimizing radiation and contrast dose on Azurion systems. [3]

How did DynamX compare with Resolute Onyx DES in BIOADAPTOR?

Elixir Medical reported lower four-year target lesion failure for DynamX versus Resolute Onyx DES in the BIOADAPTOR RCT. [4]

What endpoints did Jupiter Endovascular report for SPIRARE II?

Jupiter said SPIRARE II met primary endpoints for RV/LV ratio reduction and major adverse event rate in acute intermediate-risk PE. [5]

What FDA safety issues were highlighted?

FDA-related updates covered Johnson & Johnson Automated Impella Controller restart risk and a Class I recall for certain Terumo Aortic Relay Pro grafts. [7], [8]

Entities / Keywords

Reflow Medical, DEEPER CORONARY, Spur Elute, coronary in-stent restenosis, ISR, retrievable scaffold therapy
Acist Medical Systems, Bracco, Acist Pro, Acist CVi, contrast management, FDA clearance
Philips, SmartIQ, Azurion, ClarityIQ, coronary imaging, radiation dose, contrast dose
Elixir Medical, DynamX, BIOADAPTOR RCT, Resolute Onyx, Medtronic, DES, PCI, TLF
Jupiter Endovascular, Vertex pulmonary embolectomy system, SPIRARE II, pulmonary embolism, PE, TFX
BATMAN, TMVR, LVOT obstruction, LAMPOON, SESAME, JACC: Cardiovascular Interventions
Johnson & Johnson MedTech, Abiomed, Automated Impella Controller, Impella, FDA safety alert
Terumo Aortic, Bolton Medical, Relay Pro Thoracic Stent Graft, Class I recall, thoracic aorta