On March 2, 2018, Medeon Biodesign, Inc. entered into an asset purchase agreement for its large bore vascular closure system with Terumo Corporation of Japan. Read the press release here.

Unmet Need

An increasing number of percutaneous catheterization procedures (such as Transcatheter Aortic Valve Implantation, or TAVI) requires large-bore incisions. A major challenge with such interventions lies in achieving rapid hemostasis post procedure, and failure to do so can lead to a range of vascular and/or groin complications. The growing importance of large-bore closure devices can be seen in the expanding global market for vascular closure devices, which is projected to surpass US$600 million by 2020.

Current closure options all suffer significant disadvantages. Surgical cut-down can be risky and requires lengthy recovery time. Existing suture-based devices often require multiple devices manually rotated at different angles, which impacts the predictability and consistency of outcomes.

Our Solution

Cross-SealTM System presents a revolutionary solution to this challenge. In the beginning of the index procedure, one Cross-SealTM device delivers two pairs of sutures in three simple steps. With these pre-closure steps, two cross knots are placed at a consistent 90-degree angle above the access site.

This technology offers numerous benefits over other large-bore closure devices:

  • Consistent suture placement reduces user variability and leads to predictable outcomes
  • An inside-out deployment mechanism minimizes risk of vessel narrowing
  • Reduces the number of devices needed to close large-bore arteriotomy
  • Operator can visually verify the knots above the access site and avoid accidental locking
  • Easy to operate with a short learning curve

The Cross-SealTM System offers superior clinical performance and ease-of-use compared to other large-bore closure devices available on the market. Its safety and efficacy have been demonstrated in various large animal studies and clinical studies.