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2015 Innovation Celebration Winners

Company: Medtronic
Product: IN.PACT® Admiral® Drug-Coated Balloon (DCB)

The IN.PACT Admiral DCB is the newest minimally-invasive treatment for Peripheral Arterial Disease (PAD) in the upper leg. It features a proprietary coating of the drug paclitaxel and a naturally occurring excipient called urea, which facilitates transfer of the drug from the balloon into the artery wall. Paclitaxel is delivered in a 3.5 μg/mm2 dose to maximize therapeutic benefit and remains at therapeutic levels for up to 180 days. The device is available in 40, 60, 80, and 120 mm lengths and can accommodate vessels ranging from 4-7 mm in diameter.

Company: Flexicare
Product: DualGuard

DualGuard is an innovative solution that incorporates an endoscopy bite block with oxygen delivery and CO2 monitoring for use in upper endoscopy procedures. DualGuard enables clinicians to meet the American Society of Anesthesiologists’ (ASA) guideline of monitoring all patients during moderate and deep sedation, ensuring the safety of patients breathing orally or nasally. Additionally, DualGuard may be used before the procedure as a pre-oxygenation device and also in recovery to continue monitoring CO2 and delivering oxygen.

Company: Roche
Product: Cobas HPV Test

The cobas® HPV Test is the first and only non-Pap test approved for first-line screening of cervical cancer in the U.S., introducing a new option in screening strategies to improve women’s health.

Clinically validated by the landmark ATHENA trial, the cobas® HPV Test is the only FDA approved HPV assay that provides specific genotyping information for HPV 16 and 18, the highest-risk types, while simultaneously reporting the 12 other high-risk HPV types as a pooled result, all in one run, from one patient sample.

Company: Penumbra
Product: Apollo System

The Apollo(TM) System, a medical device developed by Penumbra, a specialty interventional therapies company based in California, is now available to remove hemorrhages from the brain in a minimally invasive way. Previously, such a condition would have limited treatment options. The Apollo System uses suction, irrigation and gentle vibration within a thin metal wand to remove soft tissue and fluid during ventricular neurosurgery.

Company: Incisive Surgical, Inc.
Product: INSORB® 30 Absorbable Subcuticular Skin Stapler

The INSORB Absorbable Subcuticular Skin Stapler is a revolutionary new patient-centric, cost-effective, rapid skin closure modality. The INSORB Stapler places an absorbable staple completely underneath the top layer of skin to close surgical incisions. The INSORB Staple is essentially absorbed within 90 to 120 days. The INSORB Stapler combines the comfort, cosmesis and convenience of absorbable suture with the speed of a metal skin stapler, while eliminating percutaneous insult of metal staples and post-operative metal staple removal. Over 1,500,000 INSORB Staplers have been sold throughout the world; over 100,000 US C-sections were closed with an INSORB Stapler (estimate) last year.

Company: ReavillMED
Product: ReavillMED One Needle

The ReavillMED One Needle is a one step device that infuses a PICC line into the arm with a simple IV push. It can be used in emergency situations where early aggressive central lines are required and also remain within the patient for long term IV therapies up to 1 year if needed. The technology is reimbursable and makes the one needle hospital stay a reality.

Company: Hologic
Product: Brevera™ breast biopsy system with CorLumina™ imaging technology*

Introducing the revolutionary new Brevera™ breast biopsy system with CorLumina™ imaging technology* from Hologic, a truly breakthrough innovation creating a new real-time category in biopsy. The Brevera system is designed to deliver a significantly meaningful difference to physicians, administrators and patients.

The system is an advanced biopsy platform designed to increase clinical confidence, reduce procedure times, and ultimately improve the patient experience. The system integrates tissue acquisition, real-time imaging and post biopsy handling providing physicians with more real-time information than ever before and streamlining workflow.

The Brevera breast biopsy system with CorLumina imaging technology –transforming breast biopsy with real-time solutions.*System not FDA cleared, not available for sale in the United States.

Company: St. Jude Medical
Product: CardioMEMS™ HF System

The CardioMEMS™ HF System is the first and only FDA-approved heart failure (HF) monitor proven to significantly reduce HF hospital admissions and improve quality of life in NYHA class III patients.

When used by clinicians to manage HF, the CardioMEMS HF System is:
Safe and reliable – 98.6% of patients were free from device or system complications1

Clinically proven – reduced HF admissions by 37%1 and all-cause 30-day readmissions by 58%2
Proactive and personalized – patient management through direct monitoring of PA pressure and titration of medications

Traditional physiologic markers in the development of acute decompensation in patients suffering from HF such as intrathoracic impedance, weight, blood pressure and symptoms are late and unreliable3,4 with only moderate sensitivity and specificity.5-7 Large randomized controlled studies using telemonitoring of these indirect markers have failed to reduce HF hospitalizations.3,4,8

Company: Toshiba America
Product: Cardiovascular X-ray Dose Solutions

Toshiba’s Infinix™ cardiovascular X-ray systems feature a comprehensive selection of tableside dose management tools to assist physicians with managing dose and delivering high quality images. Dose management tools include Spot Fluoro, Virtual Collimation, Fluoro Record/Store, Live Digital Zoom and Grid Pulsed Fluoro. Toshiba’s latest dose reduction technology, Dose Tracking System (DTS), measures peak radiation skin dose in real time during interventional procedures, allowing for safer exams and a better patient experience. DTS also offers expanded bi-plane (frontal and lateral) coverage and the ability to track cradle movement, allowing the technology to monitor dose in a wider range of applications, such as neurovascular procedures.

Company: Toshiba America
Product: Superb Micro-Vascular Imaging (SMI)

Toshiba is giving clinicians a new way to diagnose disease faster and safer with Superb Micro-Vascular Imaging (SMI) for its AplioTM 500 Platinum ultrasound system. SMI makes it possible for clinicians to use ultrasound to see the smallest vessels in and around areas like tumors and lymph nodes and visualize low-velocity microvascular blood flow without the need for contrast agents or invasive modalities.

Company: Westmed, Inc.
Product: Vibralung Acoustical Percussor
A Paradigm Shift in Respiratory Care

It’s the new sound of the Vibralung Acoustical Percussor, and it’s starting a revolution in Airway Clearance Therapy (ACT). Only the Vibralung Acoustical Percussor applies sound waves over a wide range of frequencies to vibrate the column of gas in the tracheobronchial tract. As a result, mucous is loosened and separated throughout the airways to promote safe, effective and gentle ACT like no other alternative.