Drug-eluting technologies for PAD treatments take centre stage at LINC 2015 – Lower reintervention rates dominate symposium discussions

Bloomington, Ind., May 22 2015 — Cook Medical is pleased to be one of the global medical device companies to collaborate internationally with regulatory authorities on the Medical Device Single Audit Program (MDSAP).

The value of developing a global program to audit and monitor medical device manufacturing for patient safety was recognised at the International Medical Device Regulators Forum inaugural meeting in 2012. That meeting led to the creation of MDSAP.

MDSAP International Coalition Organisations:

• US Food and Drug Administration (FDA)
• Health Canada
• Therapeutics Goods Administration (TGA) Australia
• Agência Nacional de Vigilância Sanitária (ANVISA) Brazil
• Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) Japan

‘This progressive approach to regulatory oversight is very exciting,’ said Pete Yonkman, president of Cook Medical. ‘We recognise that good collaboration among regulatory agencies and industry enables more efficient and flexible use of both regulatory and company resources.’

The MDSAP enables regulatory oversight of manufacturers’ quality management systems while minimising the regulatory burden on industry. It also promotes more efficient and flexible use of regulatory resources through work sharing and mutual acceptance among regulators while respecting the sovereignty of each authority. It also leverages, where appropriate, existing conformity assessment structures.

The Cook Medical plant in Limerick, Ireland, was chosen to trial this new auditing approach. The facility, which employs over 800 staff, underwent a two-day initial certification audit in April, which was led by TÜV SÜD of Germany. It is the first Irish site to take part in MDSAP. This audit is one of six global MDSAP audits to date.

About the Medical Device Single Audit Program:

• It is based on a three-year audit cycle.
• The initial certification audit constitutes a stage-one and stage-two audit of a quality management system.
• A partial surveillance audit takes place in each of the following two years.
• A complete recertification audit is performed after three years.

About Cook Medical
Since 1963 Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we are combining medical devices, biologic materials, and cellular therapies to help the world’s healthcare systems deliver better outcomes more efficiently. We have always remained family owned so that we have the freedom to focus on what we care about: patients, our employees, and our communities. Find out more at www.cookmedical.eu, and for the latest news, follow us on Twitter and LinkedIn.

Limerick, Ireland, February 4, 2015 – Historic five-year results from the world’s largest clinical trial of a drug-eluting stent for treating peripheral arterial disease (PAD) were presented last week at the Leipzig Interventional Course, in Germany. The data confirm long-term patency for patients treated with Zilver^® PTX^®.

Michael Dake*, MD, of Stanford University, told attendees that ‘five-year data for Zilver PTX versus bare-metal stenting confirm a sustained benefit for the paclitaxel-eluting stent and continues to show benefit through five years with no late catch-up. In fact, we see the benefit of Zilver PTX is even greater over time when compared to standard care.’

The Zilver PTX Randomised Trial of Paclitaxel-Eluting Stents for Femoropoliteal Artery Disease was a 479-patient multicentre, prospective, randomised study designed to evaluate the PTX stent as a treatment for PAD in the superficial femoral artery (SFA).

Dr. Dake presented to attendees looking for better long-term SFA results for their patients. Zilver PTX data show a 48 per cent reduction in reintervention and a 41 per cent reduction in restenosis compared to standard care[i]. It also showed 5-year primary patency of 66.4 per cent in the superficial femoral artery (SFA) for patients treated with Cook’s paclitaxel-eluting stent. This compares to 43.4 per cent patency for patients treated with standard care.

Dr. Dake chaired a symposium featuring Drs. Konstantinos Katsanos of Guys and St. Thomas’s, London; Andrew Holden of Auckland City Hospital; and Fabrizio Fanelli, Sapienza University of Rome. Live Zilver PTX cases were performed by in Leipzig and Dendermonde, Belgium.

Mark Breedlove, vice president and global business unit leader of Peripheral Intervention at Cook Medical said, ‘As the first and only endovascular SFA device with 5-year randomised controlled trial data, Zilver PTX is raising the standard for treating SFA disease. Physicians and patients welcome this clinical evidence proving the lasting effectiveness of drug-eluting devices in peripheral vessels.  This year, we will see Zilver PTX help even more patients around the world suffering the debilitating effects of PAD.’

*Dr. Dake, a global principal investigator for the Zilver PTX trial, is a paid consultant to Cook Medical regarding the research and development of medical devices.

[i] Dake M. The Zilver PTX randomized trial of treating femoropopliteal artery disease: 5-year results. Presented at the Leipzig International Course (LINC); January 27-29, 2015; Leipzig, Germany.