ES Vascular Gets CE Mark for Surgical Stapler

ES Vascular, which I wrote about a few weeks ago, has received a CE Mark of approval for its Open Aortic Stapler (OAS), enabling commercialization of the device in most European countries.  According to the press release, the device “enables one shot stapling of synthetic grafts to aorta in open repair of abdominal and thoracic aneurysmal and occlusive disease, replacing lengthy and cumbersome manual suturing in these major procedures.” 

Founded in Israel in 2003 by Prof. Edward G. Shifrin, a vascular surgery expert, ES Vascular’s staplers “form a continuous ringed line of staples with no gaps between adjoining staples to eliminate leakage and bleeding.”

Shuki Porath, CEO of ES Vascular said he is “very pleased to have received the CE Mark for our OAS device and will immediately implement our strategy to make it available in approved countries. Positive clinical data position OAS to be a break-through product for patients and physicians alike.”

ES Vascular will be presenting the OAS and other products at the MedtechInsight conference “Investment In Innovation (In3) Europe”, Paris, April 29-30.

See a video presentation of the stapler in action and check out the company’s website for detailed info on the technology.

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Surgical Stapler: ES Vascular Raises $3M

ES Vascular has developed highly-advanced surgical staplers for endovascular surgery, open aortic surgery and critical limb ischemia (CLI). Private investors have now invested $3 million in hopes that the company’s Open Aortic Stapler will soon receive the CE mark which will allow it to begin marketing in Europe. The money should also help the company complete clinical studies on its other staplers.

Founded in Israel in 2003 by Prof. Edward G. Shifrin, a vascular surgery expert, ES Vascular’s staplers “form a continuous ringed line of staples with no gaps between adjoining staples to eliminate leakage and bleeding.” The company claims that these staplers will drastically reduce complications arising from current surgical procedures.

According to its website, ES Vascular products will address a large and growing market:

  • The Company’s immediate addressable market for the Aortic Staplers includes over 120,000 patients undergoing open AAA repairs annually worldwide.
  • The US endovascular AAA device market reached close to $500 million in value in the year 2004.
  • In the US and EU 1.9 million surgical interventions are performed for patients suffering from CLI.

ES Vascular claims its staplers offer the following advantages:

  • Its Open Stapler creates a quick, uniform, one-shot sutureless anastomosis and may eliminate up to 90% of suturing time, reduce clamping and operative times as well as re-clamping cycles and bleeding.
  • Once the stapler is in place the staples are deployed in one shot, firmly fixating the stent graft to the aortic wall and possibly preventing one of the most common problems of current EVAR devices.
  • CLI Endostapler will facilitate a minimally invasive procedure that can replace an open femoral-popliteal bypass (FPB) operation. Eliminating open end-to-side anastomoses, this device will potentially improve patency rates and reduce hospitalization to a one night hospital stay.

See a video presentation of the stapler in action and check out the company’s website for detailed info on the technology.