Emboline Announces Completion of Pivotal PROTECT H2H IDE Trial Enrollment for Emboliner®, a 360° Full-Body Embolic Protection System in TAVR

EmbolineAnnounce its core productEmbolinerIDE Clinical Study (ProtectH2H) Completion of clinical enrollment.

ProtectH2H is aA prospective, randomized, open-label, multicenter study was conducted at 18 centers in Brazil, Germany, and the United States, enrolling a total of 500 subjects, with two experimental groups and a control group using Boston Scientific's product.SentinelThe primary endpoints included the 30-day incidence of major adverse cardiovascular and cerebrovascular events, 30-day stroke events according to the VARC-2 criteria, and the acute embolic debris capture rate.

PI Evaluation

"The completion of enrollment in this important trial is exciting, as it will advance our goal of providing comprehensive embolic protection for TAVR and other structural heart disease procedures. The use of a full-body embolic filter capable of capturing and removing debris will greatly enhance our confidence in protecting patients from stroke and other embolic complications."

---Tamim Nazif  Columbia University Irving Medical Center

Executive Evaluation

"Without the strong support of researchers and their teams from the United States, Brazil, and Germany, this significant milestone would not have been achieved. I am also proud of the dedication of the entire Emboline team, especially the exceptional clinical, quality, and product development teams who provided extraordinary support for this study. We are actively advancing regulatory submissions in the U.S. and Europe, looking forward to making Emboliner available to all interventional physicians to protect patients from procedural debris. The investigators' trust in our trial device further confirms the potential of Emboliner as a universal protection device, with applications that can extend beyond the TAVR field."

---Scott Russell  President and CEO of Emboline

In addition to IDE studies, researchers have also applied Emboliner in approximately 20 cases of compassionate use and emergency use involving high embolic risk, including thrombectomy, valve-in-valve procedures for aortic and mitral valves, valve repair, and left atrial appendage closure. These practices have demonstratedEmbolinerThe full-body protection capability and the trust doctors have in it.

As is known to allBoco'sSentinel is the only FDA-approvedTAVR Embolic Protection Device, butSentinel has been clinically proven to be effectiveCan capture detached emboli during TAVR but failed to show any clinical benefit.。This meansSentinel has little clinical value. This isIs the TAVR embolic protection device an unnecessary step in TAVR surgery, orDoes Sentinel have design flaws?

ExpectationThe ProtectH2H clinical study can provide answers.

EmbolinerConsidered to be the true next-generation TAVR embolic protection device.Emboliner consists of a delivery catheter and a filter.FilterThe cylindrical nitinol braid design can accommodate the vast majority of patients' anatomical structures.OverFilterProximalAnd includes an expandable entry through which the TAVR delivery system can pass, allowingOverFilterAble to capture everything throughout the entire TAVR procedureEmbolic ResidueSheet.

Advantages of Emboliner

• Simple clinical operation, can be quickly placed;

• The procedure requires only one access route (the same route as TAVR), thus eliminating the need for additional access or closure.

• Can provide 360° protection, safeguarding all branches of cerebral vessels.

• Can also protect other vital organsOfficial. PreventEmbolization ResidueTabletFlowing through the descending aorta to the kidneys, abdomen, and lower limbs, providing full-body embolic protection.

• Able to retrieve all during the operationEmbolic ResidueTablet, without the need for other equipment assistance.

• Compatible with all TAVR delivery systems. The expandable inlet of the Emboline can also accommodate small instruments and other large profile devices.

Emboliner Placement

Emboliner Protection and Retrieval