In December 1948, Albert Einstein was diagnosed with an abdominal aortic aneurysm; he was 69 years old. There was no treatment options available at the time and the only thing his physician, Dr. Rudolph Nissen, could do was to wrap his aorta with Polythene cellophane.
After a 3-week hospital stay, Einstein recovered from the operation, returned to his home in Princeton, New Jersey and lived for six more years.
In 1952 artificial vascular grafts made of Dacron where introduced as a solution. A surgeon opens the patient's chest or abdomen, depending on where the aneurysm is located, and replaces the diseased segment of the aorta with the synthetic graft.
Dr. Nissen proposed to Albert to take a chance on the new procedure but Einstein declined. He said that he lived a life that is full and has no more desire to extended it.
Einstein died three years later, in April 1955 of a ruptured aortic aneurysm, a fatal condition that claims the lives of 15,000 elderly American men each year.
In 1969 Dotter proposed the concept of using the patient's arteries as highways to reach the aneurysm with micro-catheters from within and to repair it endovascularly.
The idea was to compress a vascular graft into a tube, and place it in a retrograde, catheter-based fashion from the femoral artery and to add a metal component (stent) to prop the graft into position. The new device was named a stent graft.
In 1986 Nicholas Volodos performed the first endovascular repair of a thoracic aortic aneurysm in Ukraine. In September 1990 Parodi performed the first endovascular repair of an abdominal aortic aneurysm in Argentina.
Source: Endologix - AFX Infra-Renal Abdominal Endograft
Early aortic endografts were modified Dacron vascular grafts fashioned individually by the surgeons and reinforced with stainless steel wire. The technology evolved very rapidly when the industry took over the development process.
Today, the Aortic Endografts Market is a global $1.8 billion market that is still growing in the double digits range. Not a small feat for the medical device industry where markets are traditionally small, in the $50 to $300 million range.
Source: Aortic Endografts Market
Medtronic (MDT) leads the market with a large margin, followed by privately held Cook Medical and Gore Medical competing for second and third places.
Rumors have it that Terumo is contemplating acquiring Endologix in 2013. That makes a lot of sense. Competition in the aortic endografts pace is tough and the combined shares of both Terumo and Endologix might help both reach a sweet spot on the critical mass scale.
It will also allow Terumo access to both the US and the Japanese markets, where it, currently, has no presence. In addition, Endologix is about to launch the neatest endograft to enter the market; the Ventana.
The Ventana is a fenestrated stent graft that will extend the universe of aortic aneurysm patients eligible for endovascular repair by over 25%, which can translate to $500 million in revenue by 2017.
All other stent grafts on the market are either developed for the infra-renal abdominal aorta or for the descending part of the thoracic aorta. Any patient with an aneurysm extending to the renal artery or involving both abdominal and thoracic aortic segments, can not be treated.
Treatment would mean blocking the vital arteries that supply blood to the kidneys (renals) and the spinal cord. Paralysis and death from renal failure follows.
The Ventana solves the problem by ventilating the vital arteries through precision fenestrations incorporated in the graft body.
Only two competing products are available in this space. Cook Medical has a fenestrated stent graft (Zenith fenestrated) similar to the Ventana, which was launched in the US in April 2012. However, it is custom made to order. The patient has to wait 12 weeks to get one delivered and the price tag is in the range of $40,000 to $60,000 per device.
The second competitor is Cardiatis, a European startup that has developed a disruptive technology of the ultimate fenestrated endograft, the Multi-Layer Flow Modulator, which successfully launched in Europe last year.
Endologix can snap that one up before it gets itself acquired by Terumo, and together they can rule the $500 million thoraco-abdominal aneurysm segment of the market and continue gaining share in the remainder of the $1.8 billion aortic endografts market.