December 2, 2019
First Patient With Pulmonary Embolism Treated With Insera’s Clear Aspiration System
December 2, 2019—Insera Therapeutics, Inc. announced that Clear, the company’s cyclical aspiration system, was used for the first time to successfully treat a patient with acute pulmonary embolism.
Luka Novosel, MD, an interventional radiologist at the Sisters of Charity Hospital in Zagreb, Croatia, commented in the company’s announcement, “Due to the large clot burden in the lung arteries, the 65-year old gentleman presented with right-sided heart failure and was in critical condition. Traditional treatments using blood thinning medications such as anticoagulation and thrombolytic medications were contraindicated in this patient.”
Dr. Novosel continued, “We successfully treated this patient with massive bilateral acute pulmonary embolism using Insera’s Clear aspiration system. I am very pleased with the ease of use of cyclical aspiration and its ability to rapidly ingest large amounts of clot. It also provides a safer mechanical means of removing life-threatening blood clots without the bleeding risk associated with blood thinning medications.”
In October, the first two stroke patients were treated using the same platform. The company received European CE Mark approval for the Clear aspiration system, its flagship device, in March 2019.
The Clear aspiration system has European regulatory approval for the aspiration of blood clots; it is indicated for use for acute ischemic stroke secondary to large vessel occlusive disease, as well as the aspiration of blood clots from arteries (eg, peripheral artery disease, pulmonary embolism, and coronary artery disease) and for the aspiration of blood clots from veins (eg, in patients with deep vein thrombosis or cerebral venous sinus thrombosis or patients with renal failure who have clotted hemodialysis grafts).
Vladimir Kalousek, MD, an interventional neuroradiologist at the Sisters of Charity Hospital who has pioneered the use of cyclical aspiration, stated in the press release, “To date, we have successfully used the Clear aspiration system in nine stroke patients. I am very pleased with the higher trend of first-pass recanalization using cyclical aspiration. For example, in our very first patient, we had a 6-minute procedure time from groin to recanalization with Thrombolysis in Cerebral Infarction 3 on first-pass (complete vessel reopening on the first operative attempt)."