Secant Group, in partnership with its sister company SanaVita Medical, announced new technology to advance cardiovascular regenerative medicine with the development of a synthetic, small-bore vessel that encourages endogenous regeneration and new vessel formation. The technology is based on the company’s textile forming capabilities that can produce a hollow lumen construct infused with Secant’s proprietary Regenerez bioresorbable polymer technology. The new small-bore vessel supports the regeneration of new vascular tissue structures without the need for cell seeding or biologic growth promoters.

Miracor Medical Systems GmbH (Miracor Austria) and Miracor Medical SA (Miracor Medical) announced the closing of €25m as part of a Series D financing round. The new capital will be used to further develop and commercialize the PiCSO Impulse System. The round was led by Ming Capital (Shenzhen, China) and co-led by a strategic investor.

It is not the amount of fat in your body but where it is stored that may increase your risk for heart attack, stroke and diabetes, according to a new study presented at the annual meeting of the Radiological Society of North America (RSNA), Nov. 26-Dec. 1 in Chicago. The study looked at the differences in fat distribution patterns among overweight and obese men and women and their associated cardiometabolic risk.

The U.S. Food and Drug Administration (FDA) announced that Edwards LifeSciences is recalling its Certitude Delivery System due to a molding overflow defect in the button valve within the loader. The overflow material could detach during placement of the delivery system and potentially embolize into the patient, according to the FDA. Such an embolism could obstruct blood flow to critical organs, leading to serious injury and/or a need to surgically extract the overflow material from the patient. In dire situations, severe neurologic, cardiac, limb, renal or gastrointestinal injury may result.

The Centers for Medicare & Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (Innovation Center) announced the launch of a new voluntary bundled payment model called Bundled Payments for Care Improvement Advanced (BPCI Advanced). Under traditional fee-for-service payment, Medicare pays providers for each individual service they perform. Under this bundled payment model, participants can earn additional payment if all expenditures for a beneficiary’s episode of care are under a spending target that factors in quality.