Medtronic acquires Heartware International

Medtronic to Expand Heart Failure Portfolio with Acquisition of Heartware International

Medtronic plc

Extends Clinical and Commercial Leadership Into
Growing Circulatory Support Sector

DUBLIN and FRAMINGHAM, Mass. – June 27, 2016 – Medtronic plc (NYSE: MDT), the global leader in medical technology, and HeartWare International, Inc. (NASDAQ: HTWR), a leading innovator of less-invasive, miniaturized circulatory support technologies for the treatment of advanced heart failure, today announced that the companies have entered into a definitive merger agreement under which Medtronic will acquire HeartWare in a transaction valued at approximately $1.1 billion. Under the terms of the agreement, Medtronic will commence a tender offer for all outstanding shares of HeartWare common stock for $58.00 per share, in cash. The boards of directors of both Medtronic and HeartWare have unanimously approved the transaction. The acquisition is expected to close during Medtronic’s second fiscal quarter ending Oct. 28, 2016, subject to the satisfaction of customary closing conditions.

Medtronic’s acquisition of HeartWare will expand Medtronic’s portfolio of diagnostic tools, therapies and services for patients suffering from heart failure, aligning with Medtronic’s Mission of alleviating pain, restoring health and extending life, and is in line with the Company’s strategy to surround the physician with innovative products while focusing on patients and disease states.

HeartWare’s flagship product, the HVAD® System, features the world’s smallest full-support ventricular assist device (VAD) and is designed to reduce surgical invasiveness, improve patient recovery times and enhance patient outcomes. In addition, HeartWare has multiple technologies in development designed to offer progressively less-invasive mechanical circulatory support options for patients with end-stage heart failure. Medtronic estimates that the global VAD market is approximately $800 million currently and worldwide is expected to grow in the mid-to-high single digits for CY16-17, and accelerate to high-single/low-double digits beyond CY17.
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From Medtronic Micra Transcatheter Pacemaker System

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Latest updates on TMVI

CardiAQ™ Valve Technologies Reports First-in-Human Percutaneous Transfemoral, Transseptal Implantation with Its Second Generation Transcatheter Bioprosthetic Mitral Heart Valve

Nearly 50% of patients suffering from a diseased mitral heart valve with severe, symptomatic regurgitation are currently denied open-heart surgery because it is considered too risky; in the future, percutaneous Transcatheter Mitral Valve Implantation (TMVI) may offer new hope for these patients.
June 23, 2015 09:22 AM Eastern Daylight Time

IRVINE, Calif.–(BUSINESS WIRE)–CardiAQ Valve Technologies (CardiAQ), which has developed the world’s first self-conforming and self-anchoring technology for nonsurgical transfemoral-transseptal percutaneous Transcatheter Mitral Valve Implantation (TMVI), today announced that its second-generation bioprosthetic mitral heart valve was successfully implanted as a compassionate treatment into a 72-year-old male suffering from severe mitral regurgitation (MR 4+) with multiple co-morbidities and ineligible for alternate treatment modalities. The breakthrough TMVI procedure was performed at the Tor Vergata Hospital in Rome, Italy, by an experienced Heart Team led by Director of Cardiology, Francesco Romeo, MD and interventional cardiologist Gian Paolo Ussia, MD, also including cardiac surgeon Giovanni Ruvolo MD, anesthesiologist Pasquale De Vico, MD, and echocardiographer Valeria Cammalleri, MD. Interventional cardiologist Lars Sondergaard, MD (Rigshospitalet, Copenhagen, Denmark) and cardiovascular surgeon and inventor of the CardiAQ TMVI technology Arshad Quadri, MD (St Francis Hospital, Hartford, CT) also participated.

“These untreatable patients are the reason I founded this company, and these are the patients we need to be able to help”

“Our TMVI system is designed to make nonsurgical mitral heart valve replacement a future alternative to open-heart surgical replacement and repair,” said Rob Michiels, CEO of CardiAQ Valve Technologies. “CardiAQ currently offers the only transvessel implantation approach to treating MR. While several organizations have focused on a transapical approach to replace the mitral valve, we are the only company to have realized transfemoral-transseptal human implants,” added Michiels.

“Additional transseptal feasibility cases will take place over the next few months, and we anticipate starting the European CE Mark clinical trial for our transseptal technology by the end of summer. Meanwhile, we are about to initiate the European CE Mark trial for our transapical system, which has already completed 9 feasibility cases,” said Brent Ratz, co-founder and COO. “We are confident that the CardiAQ’s TMVI system will become a disruptive technology with an application as broad as the transcatheter aortic valve technology that was pioneered a decade ago.”

“These untreatable patients are the reason I founded this company, and these are the patients we need to be able to help,” added Dr. Quadri. “It has taken a tremendous amount of work to get to this point, but I have never been more excited about the future of this technology and of TMVI. The ability to do a fully percutaneous Mitral Valve replacement with no incisions, no bypass support, and being able to extubate the patient while still in the Cath Lab is truly remarkable.”

“We have now performed three CardiAQ TMVI cases (2 transapical and 1 transseptal) at Tor Vergata with excellent results, reducing the severe MR to trace and with no Mitral or outflow tract gradients,” said Gian Paolo Ussia, MD, primary investigator at the Rome Hospital. “We are convinced that these new procedures will in the future represent a substantial treatment improvement for our patients with mitral valve disease. Our heart team is excited to be a part of these groundbreaking clinical trials.”

About CardiAQ Valve Technologies

Privately held CardiAQ, headquartered in Irvine, Calif., has developed a proprietary Transcatheter Mitral Valve (TMV) Implant that can be delivered through multiple delivery systems, including both Transvessel-Transseptal and Transapical. Through its unique anchoring mechanism that engages and utilizes the patient’s native mitral valve anatomy, physicians will be able to accurately and securely implant a new mitral valve within a beating heart without circulatory support, thus avoiding open-heart surgery. The CardiAQ TMVI procedures are designed to be performed in a cardiac catheterization laboratory or hybrid operating room. Ultimately, the procedure will result in less trauma to the patient and substantial potential cost-savings to the healthcare system.

Caution: The CardiAQ™ Valve Technologies Systems for Transcatheter Mitral Valve Implantation are in the early phases of clinical development and will be undergoing clinical trials in the USA and overseas until further notice. The CardiAQ TMVI technology is limited by Federal law to investigaional use only and is NOT available for sale.

Ronald Trahan Associates, Inc.
Ronald Trahan, APR, 508-359-4005, x108