September 25, 2015

Stryker’s Subrahmanian to Depart

A retooling of Styker’s international group has led to the company parting ways with Ramesh Subrahmanian, who has served as president since 2011. Subrahmanian, who is based in Singapore, will step down on Dec. 31, serving in an advisory capacity until March 31 of next year. News of Subrahamian’s departure comes two months after Stryker announced second quarter results showing a nearly 10 percent drop in international sales, compared with the same three-month period in 2014.

HPRA Seeks Leadership Candidates

Ireland’s Health Products Regulatory Authority is looking for a new chief executive to take over for Pat O’Mahony, who has served as chief since 2002, when it was still known as the Irish Medicines Board. The authority rebranded itself as HPRA last year. Interested parties should send their CVs and supporting letters by Oct. 2 to hpra@amrop.ie.

TGA Explains Regulatory Process

Medical device sponsors confused by Australia’s regulatory framework can glean valuable insights from Therapeutic Goods Administration insiders and industry experts during a meeting next month just outside Canberra. Scheduled for Oct. 15 in Barton, the Devices Sponsor Information Day will feature sessions on conformity assessment and pre- and postmarket clinical evidence, and provide an example of a successful device application. Registration details are available at www.sponsor-day.org.

Medtronic Studies Lung Navigation System

Irish devicemaker Medtronic has commenced a 2,500-patient study to evaluate the impact of its superDimension navigation system, a device intended to obtain tissue biopsies from the periphery of the lungs. The system features LungGPS technology to enable electromagnetic navigation bronchoscopy procedures. ENB helps physicians access areas of the lung that are difficult to reach, allowing earlier diagnosis of lung diseases and more personalized treatment. The study will take place in 75 centers around the globe, and patients will be followed for 24 months.

Cook Gets OK for Endovascular Graft

The FDA has given its blessing to Bloomington, Ind.-based Cook Medical’s Zenith Alpha thoracic endovascular graft for the treatment of patients with isolated lesions of the descending thoracic aorta. The approval was based on two pivotal clinical trials that studied the safety and effectiveness of the device in patients with aortic aneurysm or blunt traumatic aortic injury. The graft was launched in Europe after receiving CE mark approval in 2013. Established in 1963, the company has worked with physicians to develop technologies that eliminate the need for open surgery. Today, it combines medical devices, biologic materials and cellular therapies to help deliver better outcomes more efficiently.