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covidien plc (COV) Key Developments

Covidien's Fortrex(TM) PTA Balloon Receives FDA 510(k) Clearance

Covidien plc announced U.S. Food and Drug Administration 510(k) clearance for its Fortrex(TM) over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon catheter. The Fortrex(TM) 0.035" OTW PTA balloon catheter --the next-generation high pressure solution to maintain arteriovenous (AV) access--is also intended for use in the peripheral vascular system. A common procedure is to maintain AV access in patients receiving hemodialysis for chronic kidney disease or end stage renal failure. The Fortrex(TM) PTA balloon provides physicians with a high pressure solution to crack the short, fibrous lesions that can block AV access. Furthermore, its unique engineering provides clinicians with: Optimized balloon delivery: Fortrex(TM) PTA balloon's low tip entry profile and robust, flexible shaft design combine to enable tight tracking to the wire and successful navigation in tortuous vessels. Predictable and targeted treatment: The balloon material and design permit shape retention at rated burst pressure, ensuring focused pressure on the lesion for controlled, targeted and predictable treatment. Procedural efficiency: The combination of balloon material and wall thickness enables reliable balloon rewrap and reinsertion along with a top tier deflation time, all of which contribute to the efficiency of the procedure.

Covidien Announces Favorable Results from Iliac Stenosis Study

Covidien plc has announced favorable nine-month results from the DURABILITY Iliac study, conducted with its EverFlex stent, indicated for the treatment of iliac stenosis. The nine-month results confirm the safety and effectiveness of the EverFlex and Protege GPS self-expanding stent systems for the treatment of lesions of the common and external iliac arteries. The EverFlex and Protege GPS self-expanding stent systems demonstrated strong patency rates even in difficult to treat calcified lesions in patients with iliac disease. This data, along with the robust EverFlex stent data in the superficial femoral artery, speaks to the clinical versatility of the system.

Covidien plc Announces Six-Month Results of the VeClose Pivotal Study

Covidien plc announced the six-month results of the VeClose pivotal study, which demonstrated the safety and effectiveness of the VenaSeal(TM) closure system in patients with chronic venous insufficiency (CVI) having symptomatic reflux in the great saphenous vein. The results were presented at American College of Phlebology Annual Congress (ACP 2014) in Phoenix, Ariz. The VeClose randomized controlled non-inferiority study compared the safety and effectiveness of the VenaSeal(TM) system to that of the ClosureFast(TM) endovenous radiofrequency ablation catheter. Covidien's ClosureFast(TM) catheter is an endovenous radiofrequency (RF) ablation catheter designed to collapse and close enlarged leg veins. The VenaSeal(TM) system, which is not approved and currently limited to investigational use in the United States, is a minimally invasive procedure that uses a specially formulated medical adhesive to close the great saphenous vein. Additionally, the VenaSeal(TM) system eliminates the need for surgery, thermal ablation and tumescent anesthesia. Two hundred and forty-two patients were enrolled in the trial, of which 108 were randomized to receive treatment with the VenaSeal(TM) system and 114 with the ClosureFast(TM) catheter. Twenty patients were enrolled as roll-in/training cases and treated with the VenaSeal(TM) system. The results showed outcomes for the VenaSeal(TM) system comparable with the excellent closure rates associated with the ClosureFast(TM) catheter and demonstrated non-inferiority of the VenaSeal(TM) system: At three months, the complete closure of the great saphenous veins achieved in more than 98.9% of patients treated with the VenaSeal(TM) system compared to 95.6% of patients treated with the ClosureFast(TM) catheter; The closure rate at six months was 98.9% and 94.3% for the VenaSeal(TM) system and the ClosureFast(TM) catheter, respectively; Additionally, there were no significant differences in patient reported pain during or at three days post procedure between the groups. Additionally, in October 2014, the Journal of Vascular Surgery published results from the European Sapheon(TM) Closure System Observational ProspectivE (eSCOPE) study, which demonstrated significant improvement in venous symptoms with a cumulative 12 month closure rate of 92.9%. The results also demonstrated the VenaSeal(TM) system improves patients' quality of life.

Covidien Announces Nine-Month Results of DURABILITY Iliac Study, Addition of Iliac Indication for EverFlex(TM) Stent System at VIVA 2014

Covidien plc announced nine-month results of the DURABILITY Iliac study and addition of the iliac indication for its EverFlex(TM) stent at the Vascular Interventional Advances (VIVA) 2014 conference. The nine-month results confirm the safety and effectiveness of the EverFlex(TM) and Protégé(TM) GPS(TM) self-expanding stent systems for the treatment of lesions of the common and external iliac arteries. The prospective, multi-center, non-randomized clinical study, which was led by Dr. Faries and Dr. John Rundback, co-National Principal Investigator, Holy Name Medical Center, Teaneck, N.J., enrolled 75 patients at 15 centers in the United States and Europe. Nearly 68% of patients included in the trial had moderately to severely calcified lesions. The study demonstrated 100% device success, and the primary endpoint was met with no major adverse events (MAE) at 30 days and a MAE rate of 1.3% at nine months. Secondary outcomes were also favorable. The nine month primary patency by Kaplan-Meier analysis (the ability for the treated artery to remain open) was 95.8%, and freedom from target vessel revascularization (no repeat procedure) was 98.6%. Additionally, investigators evaluated patient quality of life using two common screening tools for peripheral vascular disease, an Ankle Brachial Index (ABI) and Walking Impairment Questionnaire (WIQ). The data from the trial demonstrated significant improvements in ABI and WIQ scores at both 30 days and nine months when compared to the baseline. The EverFlex(TM) and Protégé(TM) GPS(TM) self-expanding stent systems are Nitinol stent systems that expand to a predetermined diameter to restore blood flow. The EverFlex(TM) stent, which received iliac FDA approval in 2014, previously received biliary clearance in 2006, and superficial femoral artery (SFA) and proximal popliteal (PPA) approval in 2012.

Covidien plc Reports Unaudited Consolidated Earnings Results for the Fourth Quarter and Year Ended September 26, 2014; Provides Impairment Charge for the Fourth Quarter of 2014

Covidien plc reported unaudited consolidated earnings results for the fourth quarter and year ended September 26, 2014. For the quarter, the company reported net sales of $2,734 million compared to $2,560 million a year ago. Operating income was $513 million compared to $472 million a year ago. Income from continuing operations before income taxes was $401 million compared to $443 million a year ago. Income from continuing operations was $517 million compared to $364 million a year ago. Net income was $517 million compared to $372 million a year ago. Diluted earnings per share from continuing operations were $1.13 compared to $0.79 a year ago. Diluted earnings per share were $1.13 compared to $0.80 a year ago. Adjusted diluted earnings per share were $1.15. Adjusted operating income, excluding the specified items was $663 million, compared with $530 million in the previous year. Adjusted diluted earnings per share from continuing operations, excluding the specified items were $1.15, versus $0.91 a year ago. For the full year, the company reported net sales of $10,659 million compared to $10,235 million a year ago. Operating income was $1,992 million compared to $2,132 million a year ago. Income from continuing operations before income taxes was $1,823 million compared to $2,029 million a year ago. Income from continuing operations was $1,662 million compared to $1,600 million a year ago. Net income was $1,662 million compared to $1,700 million a year ago. Diluted earnings per share from continuing operations were $3.65 compared to $3.40 a year ago. Diluted earnings per share were $3.65 compared to $3.61 a year ago. Adjusted diluted earnings per share were $4.15, up 12%. Adjusted operating income, excluding the specified items was $2.43 billion, against of $2.26 billion in the prior year. Adjusted operating income, excluding the specified items, represented 22.8% of sales, against 22.1% a year ago. In addition, during the fourth quarter of 2014, the company recorded a $94 million impairment charge to write down the in-process research and development related to its drug coated balloon platform based on the contractually agreed upon purchase price.

 

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