Cordis begins enrollment in study of lesion treatment

Cordis announced that it began the Radiancy pre-market clinical study of its vascular stent system for treating lesions in Europe.

Miami Lakes, Florida-based Cordis’ prospective, multi-center, single-arm study will assess the safety and efficacy of the S.M.A.R.T Radianz vascular stent system for the treatment of lesions in the iliac, superficial femoral or proximal popliteal arteries via radial artery access through 30-day follow-up.

According to a news release, Dr. Mercedes Guerra, the chief of angiology, vascular and endovascular surgery at the University Hospital of Guadalajara in Spain, performed the first procedure. That procedure was performed using the Brite Tip Radianz guiding sheath and the SaberX Radianz PTA balloon catheter to facilitate the delivery of the S.M.A.R.T Radianz self-expanding stent in an iliac lesion.

“My colleagues and I are pleased to have the opportunity to perform the first case in this significant clinical stud…

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Cordis among those investing $15M in Endovascular Engineering

Endovascular Engineering today announced the closing of a $15 million Series A1 financing co-led by Santé Ventures and Cordis.

The Menlo Park, California–based startup is also called E2. It’s focused on developing advanced mechanical thrombectomy technology.

Get the full story on our sister site Medical Tubing + Extrusion. 

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Cordis names new CFO

Cordis today announced that it has appointed Christopher Scully as chief financial officer.

Scully will be responsible for leading the interventional cardiovascular technology company’s financial and IT functions to accelerate Cordis’s growth.

Prior to joining the company, Scully was executive VP and CFO for PPD. He played a role in the company’s IPO and its eventual sale to Thermo Fisher Scientific for an enterprise value greater than $20 billion.

“At Cordis, we are building a platform for medical device innovation that is possible only by tapping into the experience and insight of leaders like Chris Scully,” Cordis CEO Shar Matin said in a news release. “His record of achievement reflects his acumen and proficiency in developing long-term growth strategies that produce exceptional results.”

Scully also held numerous leadership roles at Pfizer, including chief commercial officer for its essential health b…

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Cordis names new chief medical officer

Cardiovascular technology developer Cordis announced today that it appointed Dr. George Adams as its new chief medical officer.

Miami Lakes, Florida-based Cordis said in a news release that the hiring of Adams furthers its mission to differentiate itself as a technological leader and value-based global medical device company.

“We are delighted to have Dr. Adams join our team as we continue to build the new Cordis,” Corids CEO Shar Matin said in the release. “His depth of expertise in the treatment of both complex coronary and peripheral vascular disease will play a vital role in furthering our mission to improve patient care at pace with cost-effective, differentiated solutions that build on our legacy of innovation.”

Adams joins Corids with a combination of clinical practice, medical research and product development experience, the company said. He has expertise in treating peripheral vascular disease in patients with critical …

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Cordis recalls some SMART Flex vascular stent system

Cardinal Health’s Cordis recently issues a warning letter regarding an issue with its SMART Flex vascular stent system.

Santa Clara, California-based Cordis’s field safety correction action informs users that some of its SMART Flex vascular stents have the potential for distal tip dislodgment or separation due to inadequate adhesive application.

Get the full story on our sister site, Medical Tubing + Extrusion.

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Cardinal Health completes $1B sale of Cordis business

Cardinal Health (NYSE: CAH) announced today that it has completed the sale of its Cordis business to private equity firm Hellman & Friedman.

The $1 billion sales price included includes the H&F’s assumption of certain liabilities and Cardinal Health’s retention of some working capital accounts.

“As we shared previously, this divestiture demonstrates our disciplined portfolio evaluation approach, and we remain committed to investing in our strategic growth areas,” Cardinal Health CEO Mike Kaufmann said in a news release.

The deal takes place six years after Cardinal Health bought Cordis and its minimally-invasive cardiovascular technology from J&J for nearly $2 billion.

Cordis CEO Shar Matin said: “We believe that an independent Cordis company, combined with an innovative approach to bring differentiated products to market, will allow us to create incremental value for teammates, customers and investors.…

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FDA says Cordis carotid artery stent recall is serious

The FDA has classified Cordis‘ recall of its Precise Pro Rx carotid system as Class I, the most serious kind of recall.

Cordis in February recalled certain lots of its Precise Pro RX carotid stent systems because of a risk of separation of the atraumatic distal tip of the sheathed delivery system in patients.

The Precise Pro Rx is used to treat patients with narrowed carotid arteries and includes a metal (nitinol) self-expanding stent that is preloaded on a delivery catheter used to place the stent.

According to an FDA release, if the device separates during use, it may cause serious adverse events, such as the removal of the separated tip from the carotid artery, embolization distally or stroke.

To date, there have been seven complaints about the issue with the Precise Pro Rx carotid stent system. Five injuries were reported, although no deaths have been registered as a result of the issue to date.

Affected products were manufactured…

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Cardinal Health to sell Cordis for $1B

Cardinal Health (NYSE: CAH) announced today that it will sell its Cordis business to private equity outfit Hellman & Friedman (H&F) for $1 billion.

News of the deal — expected to close in the second half of 2021 — comes nearly six years after Cardinal Health bought Cordis and its minimally-invasive cardiovascular technology from J&J for nearly $2 billion.

“Our decision to divest Cordis demonstrates our disciplined approach to evaluating our portfolio and focusing our resources in our strategic growth areas where we are an advantaged owner,” Cardinal Health CEO Mike Kaufmann said in a news release. “Looking forward, we remain committed to our medical distribution and global medical products businesses.”

H&F partner Hunter Philbrick described the deal as an “excellent fit with our philosophy of investing in great businesses.”

Serial entrepreneur Duke Rohlen — CEO of Ajax Health and Zeus Health — is…

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Cordis recalls some Precise Pro RX carotid stent systems

Cordis, a Cardinal Health (NYSE:CAH) subsidiary, is recalling and removing certain lots of its Precise Pro RX carotid stent systems.

The Precise Pro RX carotid stent system, which is used in patients with stenotic lesions of the carotid arteries, has the potential for the distal tip to become separated from the wire lumen on certain lots of the system. The separation could result in an intra-procedural delay while a replacement device is prepared, unplanned percutaneous or surgical intervention or stroke, according to an urgent field safety notice.

Santa Clara, Calif.-based Cordis said it recently confirmed complaints about distal tip separation may be the result of inadequate joint adhesion. There have been no reports of strokes, deaths or other long-term patient events related to the distal tip separation.

Cordis is recommending healthcare providers check inventories to confirm if there are any units from the affected lots and to return the devices to …

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