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FDA Green Lights One-of-a-Kind Stent

FDA Green Lights One-of-a-Kind Stent

The FDA recently approved a high performance stent. Manufactured by Biotronik, the PK Papyrus platform is a covered coronary stent, a device meant to be used in the emergency treatment of acute coronary perforations

The new coronary stent, which was launched in Europe in 2013, is said to be the first FDA approved device for this indication in 17 years. PK Papyrus is a balloon-expandable covered coronary stent and delivery system that can be advanced into the perforated coronary artery vessel using a balloon catheter.

Thanks to a unique polyurethane membrane, the stent acts as a physical barrier to close the tear in the artery wall, facilitating blood flow to the heart muscle.

This life-saving procedure eliminates the need for open-heart surgery.

There are fewer than 4,000 percutaneous coronary interventions per year in the United States that require a covered stent. For this reason, the FDA classified the stent as a Humanitarian Use Device, a category is reserved for medical devices intended to treat conditions that affect less than 8,000 Americans a year.

“Perforation is very uncommon, but physicians need to be fully prepared for this emergency event,” said Marlou Janssen, president of Biotronik. “It’s unacceptable that this critical care area has seen no innovation in nearly two decades.”

During the approval process, the FDA reviewed real-world survey data from 80 patients. The stent was successfully delivered to the perforation site in 95% of the patients, and it successfully sealed the perforation in 91.3% of the cases.

Stents have made a significant impact in the field of interventional cardiology. Coronary artery disease (CAD), the leading cause of death in the United States in both men and women, is now being treated without open heart surgery.

Instead, patients receive angioplasty surgery. First performed in the U.S. by Dr. Simon Stertzer in 1978, this non-invasive procedure relies on small balloon-tipped stent. Each year, about 600,000 Americans undergo angioplasty surgery, considerably more than those having a bypass.

Biotech companies are just starting to scratch the surface in terms of what stents can do; It might take another decade and countless clinical trials before these devices will reach their full medical potential.

Although it may take many years and clinical trials, success will be driven by innovation and out of the box thinking. In the words of Dr. Simon Stertzer, “Real change in healthcare comes with imagination and subsequent innovation: thinking in new and different ways; trying things that were previously deemed inconceivable.”

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