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FDA: Thrombolex products can treat PE


A New Britain Borough-based developer and distributor of catheters has earned FDA clearance to market two of its devices for treatment of acute pulmonary embolism.

The U.S. Food & Drug Administration cleared Thrombolex Inc.’s flagship product — the BASHIR Endovascular Catheter — and its BASHIR S-B device after favorable results from a clinical trial.

Marvin Woodall is executive chairman of the Thrombolex Board of directors. He is also on the board at the Bucks County Herald Foundation.

The FDA requires so called 510(k) clearance when a medical device manufacturer intends to market and distribute a product for the first time, or to reintroduce one that’s undergone a significant change.

The BASHIR catheters’ design allows physicians to more effectively treat large blood clots associated with deep vein thrombosis and pulmonary embolism by delivering a low dose of clot-dissolving tPA medication directly to where it’s needed most.

Pulmonary embolism is the third-leading cause of cardiovascular death in the United States.

The device is threaded through a vein to the site of the blood clot, where an “infusion basket” near the tip of the catheter is expanded in the clot to rapidly restore blood flow. This also allows for substances in the patient’s own blood to help the tPA do its job.

“Standard of care is treatment with blood thinners; however, with large clots that cause the right ventricle to fail, this is less likely to be effective,” said a summary of the trial outcomes that was sent to the National Institutes of Health. “In these patients, medications like tPA (tissue plasminogen activator) that can dissolve the clot, have been used. The problem is that when this medication is given in the peripheral veins, the dose required is 100 mg over two hours and this is associated with 10-20% major bleeding and 2-3% bleeding into the brain.”

Thrombolex received a $1 million state grant in late 2019 to support the RESCUE clinical trial, which studied 109 patients in 18 hospitals nationwide. The results showed a greater than 30% reduction in right heart strain and in the amount of pulmonary artery obstruction.

“This represents a significant advance in the treatment of acute PE, with a rapid reduction in right ventricular strain and less than 1% rate of major bleeding,” said Dr. Kenneth Rosenfield, the Massachusetts doctor who served as co-principal investigator of the RESCUE Trial, in a press release.

The cleared BASHIR catheters are available for shipment to domestic hospitals and, according to the release, Thrombolex is scheduling installation and training sessions for its customers.

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