Countach Medical

Unitary Stent Graft Platform

Designed to fit the patient. Not the other way around.

Countach Medical is converting a physician-modified design with more than a decade of clinical experience into an off-the-shelf system for the visceral aorta.

See the technology Clinical experience
Illustration of the complete Unitary stent graft system in the aorta
CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use. The Unitary Stent Graft Platform is not approved or cleared by the FDA and is not available for sale.

The problem

Patients with challenging aortic anatomies are significantly underserved

Most endovascular devices are built around typical anatomy. Many patients do not have it. Unitary was engineered for the anatomy physicians see in practice.

3D reconstruction of a typical aorta
Typical aorta
3D reconstruction of a tortuous, distorted aorta
Challenged aorta
Aorta with the visceral segment highlighted

Clinical need

One of the undertreated danger zones of the aorta

The visceral aorta is where the vessels to the gut and kidneys branch off. Patients and physicians need a new option here.

  • Complex aneurysms

    Patients present with distorted anatomy that is difficult to treat with fixed-geometry devices.

  • Failed prior endovascular repairs

    Earlier repairs further compound anatomic distortion and alignment challenges.

The technology

Engineered for favorable flow dynamics

Unitary is designed around how blood naturally flows, with the aim of balanced organ perfusion, instead of around fixed branch geometry.

Parallel-flow architecture

Preserves a more natural direction of blood flow.

Mobile visceral limbs

Align with the patient’s anatomy.

Fewer abrupt changes

A smoother route along the flow path.

Continuous visceral perfusion

Maintained during reconstruction.

Computational flow streamlines through the Unitary design, colored by velocity
Computational flow model of the Unitary architecture (velocity streamlines)

The Unitary system

A modular platform, built from five elements

  1. Unitary Paravisceral main bodyPlaced above the visceral vessels
  2. Bridging stents 1–4Celiac, SMA, and left and right renal arteries
  3. Visceral bypassCarries flow past the visceral segment
  4. Infrarenal bifurcationA standard bifurcated device
  5. Iliac extensions 1 & 2Complete the repair
Photograph of a physician-modified Unitary main body

From physician-modified to company-manufactured

Today, the Unitary main body is a physician-modified endograft made from off-the-shelf components.

Countach Medical intends to replace it with a company-manufactured version that is placed identically to the current physician-modified device.

The procedure

How the Unitary system comes together

Completed repair with the full Unitary system

Clinical experience

More than a decade of experience in patients

The Unitary design has been studied in a prospective, physician-sponsored investigational device exemption (PS-IDE) clinical evaluation reviewed by the FDA.

200+patients treated*
10+years of follow-up
3physicians
4centers
0%Screening failure rate
99%Technical success rate
3%In-hospital mortality or major complication rate
97%1-year primary patency
  • Broad, complex patient population with no anatomical restrictions
  • Perfusion of four main target vessels: SMA, celiac, and left and right renal arteries
  • Includes complex anatomy and failed prior repairs

*Patient counts: 200+ includes all device iterations since 2012; 126 are Unitary Stent Graft implants. Results shown are from the physician-sponsored IDE experience with physician-modified devices. The company-manufactured Unitary device has not yet been studied in humans, and the safety and effectiveness of the Unitary Stent Graft Platform have not been established.

Progress

Fourteen years of iterative development

  1. First patient treated
  2. PS-IDE granted by FDA; clinical trial initiated
  3. First Unitary compassionate-use patient
  4. First Unitary case under the PS-IDE
  5. Second study site launched
  6. FDA Breakthrough Device designation
  7. Pre-submission with FDA
  8. Two clinical publications
  9. Countach leadership team established

What comes next

Manufacturing

Transferring the design to an ISO 13485 contract manufacturer so every device is built under a commercial quality system.

Regulatory

Working with FDA toward a company-sponsored IDE and a premarket approval (PMA) pathway.

Clinical

Planned initial focus on failed prior endovascular repairs, with a roadmap toward broader complex aneurysm indications, including dissection and thoracoabdominal aneurysm.

  • Manufacturing transfer
  • Quality system
  • Design verification
  • FDA alignment
  • Pivotal trial
  • PMA submission

Team

Experienced in aortic devices

Mike Markert

Mike Markert

Chief Executive Officer

40+ years of M&A and cardiovascular experience

Patrick Kelly, MD

Patrick Kelly, MD

Founder and Inventor

Vascular surgeon and inventor of the Unitary design

Scott Rush

Scott Rush

Founder and Chief Operating Officer

30+ years of aortic device experience

Nan Kelly

Nan Kelly

Founder and Board Chair

Corporate leadership

Susan Simko

Susan Simko

Chief Financial Officer

25+ years of financial leadership

Clinical advisors

Naiem Nassiri, MD

Naiem Nassiri, MD

Founding Director, The Vascular Care Group (TVCG) CARES; Adjunct/Volunteer Faculty in Surgery, Yale University School of Medicine and Yale New Haven Hospital

Geoffrey A. Answini

Geoffrey A. Answini

Chief of Cardiothoracic Surgery, The Christ Hospital

Contact

Get in touch with Countach Medical

Physicians, clinical sites and industry partners are welcome to reach out.

info@countachmedical.com