Artivion announces positive trial results for its On-X mitral valve replacement

Artivion (NYSE:AORT) today announced positive results from a clinical trial for its On-X mechanical mitral valve replacement (MVR).

Atlanta-based Artivion (formerly CryoLife) published results in The Annals of Thoracic Surgery. The Proact clinical trial, a multicenter, non-inferiority, two-arm study assessed whether, after an On-X MVR, patients could be safely managed with lower-intensity warfarin plus aspirin.

The trial observed patients after their On-X mechanical MVR followed by at least three months of standard anticoagulation. In total, 401 patients across 44 North American centers were randomized to low-dose warfarin (target INR of 2.0 to 2.5) or standard-dose warfarin (target INR of 2.5 to 3.5). All patients were prescribed aspirin (81 mg daily) and encouraged to use home INR testing. Mean patient follow-up was 4.1 years with a maximum follow-up of eight years.

Artivion observed no differences in bleeding, valve thrombosis or thromboembolism rates…

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CryoLife announces corporate rebrand, changes name to Artivion

CryoLife today announced that it is rebranding itself and changing its name to Artivion, effective immediately.

The Kennesaw, Georgia-based company’s new name, derived from the words ‘aorta,’ ‘innovation’ and ‘vision,’ reflects its focus on creating devices to treat aortic disease. The company will also change its ticker symbol on the New York Stock Exchange to ‘AORT’ on January 24.

“Through a combination of legacy products and strategic acquisitions and divestitures over the last five years, we have transformed from a tissue and adhesives focused company to one with a premier portfolio of aortic products,” CEO and president Pat Mackin said in a news release. “Today marks an important milestone for our company. We look forward to embarking on our next chapter as a leader in developing simple, elegant solutions to address cardiac and vascular surgeons’ most difficult clinical challenge…

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CryoLife buys Ascyrus Medical

CryoLife (NYSE:CRY) announced today that it will acquire Ascyrus Medical and its Ascyrus Medical Dissection Stent.

The financial terms of the deal were not disclosed.

AMDS is an aortic arch remodeling device used for the treatment of acute type A aortic dissections. The acquisition will strengthen CryoLife’s position in the growing aortic repair market, according to company officials.

“We believe the addition of the AMDS to our product offerings will make a meaningful contribution to our future growth as it gives us immediate access to the combined $100+ million EU and Canadian markets and has the potential to expand our worldwide addressable market by approximately $540 million,” CryoLife CEO Pat Mackin said in a news release.

“AMDS is another highly differentiated device that, when included in our commercial channel, will further solidify our position as a global leader in aortic repair, as it will immediately strengthen…

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CryoLife prices $100m offering

CryoLife Inc. (NYSE:CRY) announced today that it priced its previously announced offering of convertible senior notes at $100 million.

Yesterday, the Atlanta-based company said it is offering the 4.25% notes, due in 2025, as well as a 13-day option for the initial purchaser to buy up to an additional $15 million in notes, which will be senior unsecured obligations of the company.

CryoLife expects the sale to the initial purchaser to settle on June 23, subject to customary conditions, with the company receiving approximately $96.5 million in net proceeds, or $111.1 million if the initial purchaser exercises its option to purchase additional notes in full.

The notes will bear interest at a rate of 4.25% per year, with interest payable semiannually in arrears on Jan. 1 and July 1 of each year, beginning on Jan. 1, 2021. The notes will mature on July 1, 2025, unless earlier converted, redeemed or repurchased.

According to a news release, the initial c…

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CryoLife announces $100m offering

CryoLife Inc. (NYSE:CRY) announced today that it intends to offer a private placement of convertible senior notes worth $100 million.

The Atlanta-based company is offering the notes, due in 2025, as well as a 13-day option for initial purchasers to buy up to an additional $15 million in notes, which will be senior unsecured obligations of the company, according to a news release.

Notes in the offering will pay interest semiannually and mature on July 1, 2025, unless earlier converted, redeemed or repurchased. The final terms of the notes, including interest rate, conversion rate and other terms will be determined by negotiations between CryoLife and the initial purchasers.

CryoLife intends to use the proceeds for general corporate purposes, including the repayment of approximately $30 million outstanding under its revolving credit facility. Any additional proceeds from the 13-day option will also go toward general corporate purposes.

The company d…

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15 heart devices that could boost their manufacturers’ sales

(Image from Cardiovalve)

Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices.

Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures.

Now hospitals are looking at ways to safely return to business-as-usual — they and the medical device industry as a whole hope to improve their balance sheets. For example, Medtronic (NYSE:MDT) CEO Geoff Martha and CFO Karen Parkhill expressed optimism in an analyst call today that their company’s businesses already are showing signs of a rebound in the month of May.

Get the full story on our sister site, Medical Design & Outsourcing.

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