PQ Bypass, Inc. announces the appointment of medical device executive Stanton J. Rowe to its Board of Directors. As the medical technology company continues to achieve clinical milestones in its development of treatments for long blockages in leg arteries from PAD, expansion of the Board is important to meet the needs for future market expansion and commercialization. Rowe’s experience and expertise will contribute significantly during this critical phase for the company.

Rowe is currently CEO of NXT Biomedical, a medical device incubator funded by Deerfield Capital. He recently retired from Edwards Lifesciences, where he was Chief Scientific Officer since 2008 and also served as Corporate Vice President, Advanced Technology. He joined in 2004 when Edwards acquired Percutaneous Valve Technologies, a company he helped to found in 1999 and where he served as President and CEO. This company developed the first transcatheter aortic valve replacement

“We are pleased to have Stan join our Board; given his extensive experience in emerging technologies, he will provide important insight to the organization during this pivotal time in the company,” said Richard Ferrari, Chairman and CEO of PQ Bypass. “Stan’s experience as both a Chief Executive Officer and Board member of many novel companies will bring immense value as we continue to develop this endovascular approach to helping those suffering from long-lesion peripheral vascular disease.”

Previously, Rowe was Corporate Vice President for Datascope and Vice President at Johnson & Johnson’s Interventional Systems Division (JJIS), responsible for the company’s coronary stent development efforts. At JJIS and the related Cordis Corporation, Rowe held a variety of positions with increasing levels of responsibility, including heading the company’s business development, advanced technology, worldwide clinical research and marketing groups.

“I am looking forward to contributing on the Board to advance this groundbreaking and important technology,” said Rowe. “The PQ Bypass solution has the potential to transform the treatment of long-segment peripheral artery disease, for which there are currently limited viable and durable endovascular options available for patients in need of revascularization. I am pleased to be a part of the team working on this novel approach for this underserved population.”

Rowe is on the Board of Directors of both InSeal Medical, Ltd. and NeuralAnalytics. He is also on the Board of Directors for Orange County’s Discovery Science Center and Sage Hill School, as well as the advisory boards for the Engineering, Business School, and Biomedical Engineering schools at UC Irvine. Rowe received a bachelor’s degree from the University of Alabama.

About PQ Bypass
PQ Bypass, Inc. is a Silicon Valley-based medical device company working to transform the treatment of long-segment peripheral artery disease with minimally invasive endovascular solutions.
PQ Bypass is operated by recognized leaders in the medical device industry including veterans from Medtronic, Abbott, Johnson & Johnson and Stryker. The underlying technology and technique used in the percutaneous DETOUR procedure were co-developed by two world-renowned cardiologists and innovators, Dr. James Joye and Dr. Richard Heuser, who are recognized experts in peripheral artery disease.
The DETOUR™ System is an investigational device and is limited by United States law to investigational use only. It is not available for sale. For more information, please visit www.pqbypass.com.

Contacts
Chris B. Ernst
C4wardcomm@gmail.com
415.710.9445

SOURCE: https://www.businesswire.com/

Meditrial Europe reaffirms its commitment to continued innovation and leadership in the field of clinical research and digital data management for the medical device industry, being one of the first and very few CROs to achieve ISO 9001:2015 certification.

Meditrial’s independent assessment and certification was performed by accredited UK registrar Bureau Veritas Certification Holding SAS.

“When clients entrust their project to Meditrial, they can be confident that the work will be conducted in accordance with the highest quality standards.” said Meditrial’s Medical Director Dr. Monica Tocchi.

“It’s a seal that guarantees the solid processes governing all aspects of Meditrial’s operations,” said Meditrial’s R&D and Quality Manager Daniele Zago, who coordinated the ISO 9001 certification audit. “The certification is confirmation that all systems are in place to meet clients’ expectations regarding cost, delivery time and, most importantly, quality of service.”

What is ISO 9011:2015
ISO 9001 is an evidence-based set of standardized requirements designed to enable an organization’s Quality Management System (QMS) to meet customer, statutory, regulatory and internal requirements, including quality, cost, and delivery time.

The ISO 9001 standard was created by the International Organization Standardization (ISO) through collaboration with experts from multiple global organizations and is considered a best practice around the world.

ISO 9001:2015, the latest edition of ISO’s flagship quality management systems standard, is a worldwide quality standard that helps organizations demonstrate that they offer products and services of consistently good quality.
“All companies certified to ISO 9001:2008 have three years to transition to the new standard due to the complexity of the new requirements,” said Daniele Ceccarelli, Meditrial’s legal manager. “We are pleased to tell our customers that Meditrial continues to lead the industry in compliance and innovation.”

What does it mean for our clients?
Our aim is to achieve the highest performance in clinical trials. This certification reaffirms our commitment to meeting client requirements, upholding the highest quality standards, and continuously improving processes throughout our multinational organization.

A well-structured quality system is critical to the success of sponsors’ work. ISO certification provides third party validation of our commitment to a quality-first approach and helps further set Meditrial apart from other CROs.

Certified services
Meditrial’s medical device services are certified as conforming to the Quality Management System Requirements ISO 9001:2015. These services include:

• Regulatory document development, preparation and submission, including clinical evaluations, literature reviews, Investigation protocols, Investigator Brochures, Risk Management documentation, and Technical Files
• Clinical trial design, study management, monitoring, data management and statistical analysis in compliance with ISO 14155
• Cloud based digital data management software solutions, Catchtrial and Fastrial
• Quality system implementation, training, auditing, and compliance to ISO and CEN standards, and European Union (EU) quality requirements
• European Representative Services
• General consulting and special projects

About Meditrial
Meditrial is a leading provider of clinical trial services and digital cloud based data management solutions for the medical device industry. Established in 2008, today Meditrial is a trusted expert partner for the more advanced corporations or early start-ups needing support and outsourcing to execute trials in Europe.
Headquartered in Zürich, Meditrial is also active in Berlin, Rome and New York.
Learn more at: www.meditrialeurope.com – www.catchtrial.com – www.fastrial.com.

HighLife SAS, an early-stage medtech company focused on the development of a unique trans-catheter mitral valve replacement (TMVR) system to treat patients suffering from mitral regurgitation, announced the closing of a €12.3 million investment round led by Sofinnova Partners which becomes the main investor in the company. HighLife had previously secured financing from a corporate player, LivaNova PLC, which also participated in this financing round along with Georg Börtlein, the CEO and founder of the HighLife.

Based in Paris (France), HighLife was started in 2010 by Georg Börtlein, who was previously a co-founder with Professor Jacques Séguin and Chief Operating Officer at CoreValve Inc., a pioneer in the development of trans-catheter aortic valve implantation supported early on by Sofinnova Partners until the sale to Medtronic in 2009 for more than $700 million.

“We are excited to invest in HighLife and believe that their unique trans-septal approach is the next innovative disruption in trans-catheter valve technologies,” said Antoine Papiernik, Managing Partner of Sofinnova Partners, “We are also happy to partner with Georg Börtlein for the second time and confident that HighLife’s technology represents the next generation TMVR product needed to reach meaningful clinical adoption.”

“This investment enables us to implement our aggressive development plan and move forward with both our ongoing clinical programs and our R&D pipeline. We are currently recruiting patients in several European countries including France and Germany and are now planning to accelerate the enrollment in this initial clinical phase.” said Georg Börtlein.

The HighLife technology relies on the initial placement of a ring component around the native mitral leaflets in a reversible manner. Once this first component’s position is confirmed, the bioprosthesis is delivered within minutes through the ring and finds its natural position inside the native annulus regardless of the access site. This approach allows for trans-septal access and delivery of the bioprosthesis after navigating up the femoral vein and reaching the native mitral valve via a puncture through the inter-atrial septum. Such route alleviates the need for a trans-apical puncture in the weakened heart muscle and is favored by physicians because further trauma to the patients is avoided.

About HighLife
HighLife SAS, headquartered in Paris, France, with offices in Irvine (California), is an early-stage company established in 2010. It is focused on the development of a novel transcatheter replacement system for treating mitral regurgitation. The technology aims at a beating heart procedure reducing trauma to the patients.
Caution: The HighLife Transcatheter Mitral Valve is an investigational device and not available for sale.
For more information: www.highlifemedical.com

About Sofinnova Partners
Sofinnova Partners is an independent venture capital firm based in Paris, France. For more than 40 years, the firm has backed nearly 500 companies at different stages of their development – pure creations, spin-offs, as well as turnaround situations – and worked alongside key entrepreneurs in the Life Sciences industry around the globe. With over €1.6 billion of funds under management, Sofinnova Partners has created market leaders with its experienced team and hands-on approach in building portfolio companies through to exit. For more information, please visit: www.sofinnova.fr

BioVentrix, Inc. a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), announced enrollment of the first patient in the U.S. arm of the ALIVE pivotal clinical trial. The trial is designed to demonstrate the safety and effectiveness of the Revivent TC™ TransCatheter Ventricular Enhancement System; a hybrid closed-chest procedure to treat patients suffering from heart failure symptoms related to cardiomyopathy. BioVentrix previously received investigational device exemption (IDE) approval for the study from the U.S. Food and Drug Administration (FDA).

The Less Invasive Ventricular Enhancement™ or LIVE™ procedure was performed at the UPMC Heart and Vascular Institute by interventional cardiologist Dr. Catalin Toma and cardiothoracic surgeon Dr. Christopher Sciortino. The device was successfully implanted with three micro-anchor pairs in a 42-year-old female patient suffering from ischemic heart failure.

“UPMC remains at the forefront of implementing promising less invasive therapies to address the need for better heart failure treatment. We are pleased to be the first U.S. center to implant the Revivent TC System as part of the ALIVE clinical trial. The procedure aims to reshape the left ventricle, decrease the Left Ventricular End Systolic Volume Index (LVESVI), and increase the Ejection Fraction (EF). The patient was discharged shortly after the procedure and is recovering well,” said Dr. Toma.

“The LIVE procedure is less invasive and less traumatic than conventional surgical reconstruction. It expands the patient population that can be treated by reducing the procedural risk. The patient was able to undergo this procedure without having to perform a sternotomy or employ cardiopulmonary bypass,” said Dr. Sciortino.

The ALIVE trial plans to enroll 120 patients at up to 20 sites in the U.S. and U.K. with a primary endpoint analysis at 1 year. The trial endpoints include positive effects on volume reduction, ejection fraction, quality of life (QOL), New York Heart Association (NYHA) Class, 6 minute walk test, and rehospitalization. Readmission rates following heart failure hospitalization remain high using standard therapies, with ≥ 50% of patients readmitted to hospital within 6 months of discharge. Left Ventricular volume reduction has been shown to significantly impact short and long-term survival rates. Annually, over 1 million patients are hospitalized with a primary diagnosis of heart failure, accounting for a total Medicare expenditure exceeding $17 billion.

About BioVentrix and the Revivent TC System
BioVentrix, a privately held medical technology company headquartered in San Ramon, Calif., is focused on developing and commercializing minimally invasive therapies for treating HF. The company has received CE mark certification for its closed-chest Revivent TC TransCatheter Ventricular Enhancement System for plication of scar tissue in post-MI, ischemic cardiomyopathy patients. Placement of the Revivent TC System via the LIVE procedure obviates the need for more invasive surgery. Instead, small titanium anchors are placed along the outer surface of the heart and along one of the interior walls via a catheter-based approach. The anchors are then pulled towards one another, effectively excluding the scarred and non-functioning heart wall. Ventricular volume is immediately reduced as a result of the exclusion, by as much as 30-40 percent.

Click here for corporate video with animation

Note: The Revivent TC System is approved for sale in Europe; it is not approved for sale in the United States

Contact: David Schickling, VP of Sales and Marketing, +1-925-830-1000.

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, announces that it has received the approval to perform, within the framework of the PIVOTAL study protocol approved by the ANSM (French national agency for the safety of medicines and health products), implants of its total artificial heart in human patients at the National Research Center for Cardiac Surgery (Astana, Kazakhstan).

The National Research Center for Cardiac Surgery is a world reference in cardiology and a leading center in clinical studies for heart devices intended for the European market, with over 8,000 surgeries carried out in 2016 including 31 heart devices implanted and 15 heart transplants.

Moreover, the center benefits from an excellent postoperative patient follow-up. It also has substantial patient enrollment potential and considerable experience in clinical trials ahead of innovative medical devices commercialization. The facility is currently in the enrollment and CT scan (thorax scanners) screening phase aimed at identifying eligible patients who can be implanted with the CARMAT bioprosthesis.

The implants will be performed by the team headed by Dr. Yuriy Pya, CEO of the National Research Center for Cardiac Surgery, and an internationally recognized surgeon in the field of heart device implants.

Dr. Yuriy Pya, comments: “The CARMAT artificial heart offers a new approach to the treatment of terminal heart failure, and we are delighted to provide our expertise to this promising project for patients suffering from this severe and irreversible condition. The approval from the Ministry of Health of the Republic of Kazakhstan has now been obtained and we look forward to implanting the device in a crucial study for the future of this disruptive innovation.”

Stéphane Piat, CEO of CARMAT, adds: “The National Research Center for Cardiac Surgery is a world-renowned facility that is particularly recognized for the excellent care provided to cardiac patients and for its expertise in clinical trials for devices destined to the European market. Postoperative follow-up is one of the key selection criteria when we select facilities, and we are very pleased to be able to count on the local teams’ know-how. In line with our clinical strategy and CE marking process, we are reinforcing our efforts to expand the PIVOTAL study to other countries, and plan to sign new collaborations shortly.”

About CARMAT

A credible response to end-stage heart failure: CARMAT aims to eventually provide a response to a major public health issue associated with heart disease, the world’s leading cause of death: chronic and acute heart failure. By pursuing the development of its total artificial heart, CARMAT intends to overcome the well-known shortfall in heart transplants for the tens of thousands of people suffering from irreversible end-stage heart failure, the most seriously affected of the 20 million patients with this progressive disease in Europe and the United States.

The result of combining two types of unique expertise: the medical expertise of Professor Carpentier, known throughout the world for inventing Carpentier-Edwards® heart valves, which are the most used in the world, and the technological expertise of Airbus Group, world aerospace leader.

Imitating the natural heart: given its size, the choice of structural materials and its innovative physiological functions, CARMAT’s total artificial heart could, assuming the necessary clinical trials are successful, potentially benefit the lives of thousands of patients a year with no risk of rejection and with a good quality of life.

A project leader acknowledged at a European level: with the backing of the European Commission, CARMAT has been granted the largest subsidy ever given to an SME by Bpifrance; a total of €33 million.

Strongly committed, prestigious founders and shareholders: Airbus Group (Matra Défense), Professor Alain Carpentier, the Centre Chirurgical Marie Lannelongue, Truffle Capital, a leading European venture capital firm, ALIAD, Air Liquide’s venture capital investor, CorNovum, an investment holding company held 50-50 by Bpifrance and the French State, the family offices of Pierre Bastid (ZAKA) and of Dr. Antonino Ligresti (Santé Holdings S.R.L.) as well as the thousands of institutional and individual shareholders who have placed their trust in CARMAT.

For more information: https://www.carmatsa.com

Boston Scientific Corporation (NYSE: BSX) announced a definitive agreement to acquire Apama Medical Inc., a privately-held company that is developing the Apama Radiofrequency (RF) Balloon Catheter System for the treatment of atrial fibrillation (AF).
The transaction consists of $175 million in cash up-front and a maximum of $125 million in contingent payments over the period of 2018-2020 based on achievements of clinical and regulatory milestones.

AF, a common heart rhythm disorder estimated to affect more than 33 million people worldwide,1 is commonly treated with anti-arrhythmic drugs as well as cardiac ablation – the process of delivering energy to the areas of the heart muscle causing an abnormal rhythm. The standard of care in AF ablations is pulmonary vein isolation (PVI) – the application of energy to create lines of scar tissue around the pulmonary veins in the left atrium to block unwanted electrical signals that trigger AF. PVI is currently performed using two different technologies: point-by-point RF-based ablation and single-shot balloon-based ablation.

The Apama RF balloon – a single-shot, multi-electrode technology – is designed to combine the primary benefits of both RF point-by-point and balloon-based ablation approaches, notably the ability to deliver differentiated levels of energy and shortened procedure times. The technology incorporates built-in digital cameras with LED lights and sensing electrodes on the balloon which allow for real-time visualization and assessment of catheter electrode contact. This is intended to provide physicians with higher confidence of effective energy delivery and the ability to customize the amount of energy delivered around the circumference of the balloon, while further reducing procedure times when compared to existing balloon technologies.

“The acquisition of Apama further advances our continued investment in the electrophysiology category, and, upon commercialization, would broaden our portfolio of differentiated arrhythmia solutions,” said Joe Fitzgerald, president of Rhythm Management, Boston Scientific. “We are also excited about the ability to integrate the Apama RF balloon system with our RHYTHMIA HDx™ Mapping System to provide physicians with an unprecedented visualization of the heart during ablation procedures.”

Initial results of AF-FICIENT, a first-in human study presented at the AF Symposium Annual Meeting in January, 2017, demonstrated the Apama RF balloon met the safety and efficacy study endpoints, achieving successful PVI in patients with paroxysmal AF.

“Study results reinforce the Apama RF balloon is an advancement in single-shot technology for PVI and can provide physicians with greater control and efficiency when performing AF ablations,” said Kenneth Stein, M.D., senior vice president and chief medical officer, Rhythm Management and Global Health Policy, Boston Scientific. “We look forward to continuing the development and commercialization of this novel ablation solution to treat both paroxysmal and persistent AF.”

The Apama RF balloon is currently being studied in clinical trials in Europe to serve as the basis for CE mark approval, which is expected in late 2018.

Apama is based in Campbell, California, with approximately 40 employees. The acquisition is projected to close during the fourth quarter of 2017, subject to customary closing conditions. On an adjusted basis, the transaction is expected to be immaterial to Boston Scientific adjusted earnings per share for 2017 and 2018. The transition is expected to be more dilutive on a GAAP basis, due to amortization expense, transaction, and integration related costs.

The Apama RF Balloon Catheter System is a concept device and not available for sale.

About Boston Scientific

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.

CONTACTS:
Trish Backes
Media Relations
(651) 582-5887 (office)
Trish.Backes@bsci.com

Susie Lisa, CFA
Investor Relations
(508) 683-5565 (office)
investor_relations@bsci.com

Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) reported today, in a non-precedential opinion, a panel of the United States Court of Appeals for the Federal Circuit affirmed the judgment of the United States District Court for the District of Massachusetts in the case of CardiAQ Valve Tech., Inc. v. Neovasc Inc. The panel also affirmed the district court’s decision not to enjoin Neovasc’s Tiara™ program.

In summary, if the judgement is not altered through additional appellate proceedings, Neovasc must pay the full judgement of approximately US$112 million, of which approximately US$70 million is already held in an escrow account. There are no other monetary damages arising from this award. Neovasc remains the joint inventor of the ‘964 patent, one of the patents in the Tiara™ patent family, along with two employees of CardiAQ Valve Technologies, Inc., both parties having freedom to use the patent without an obligation to pay royalties to the other.

Neovasc is presently considering whether to pursue further appellate review of the panel’s decisions on the other issues presented by the judgment and will continue to evaluate all other options.

About Neovasc Inc.
Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include the Neovasc Reducer™, for the treatment of refractory angina which is not currently available in the United States and has been available in Europe since 2015 and the Tiara™, for the transcatheter treatment of mitral valve disease, which is currently under investigation in the United States, Canada and Europe.

SOURCE Neovasc Inc.
http://www.neovasc.com/news-releases/

The new guidance has been updated to reflect the latest research since the last guidelines were published in 2014.

Specifically, the focused update includes changes in
– indications for antibiotic prophylaxis for infective endocarditis,
– the use of direct oral anticoagulants among patients with atrial fibrillation and heart valve disease,
– indications for transcatheter aortic valve replacement (TAVR),
– surgical management of patients with primary and secondary mitral regurgitation, and
– management of patients with a heart valve prosthesis.

Of note, the focused update modifies some recommendations for surgical aortic valve replacement (SAVR) and TAVR based on the results of clinical trials. SAVR, for example, is recommended for people with advanced aortic stenosis who have low or intermediate risk of surgery for either symptoms or other indications of future problems. For patients with advanced aortic stenosis who have symptoms, such as shortness of breath and fatigue, and are at intermediate or high risk of surgery, the writing committee found that TAVR is a reasonable alternative to SAVR. They explain that the decision to undergo SAVR or TAVR should be a shared decision in consultation with the patient, surgeon and cardiologist to determine the best option based on the patient’s needs and preferences. The shared decision-making approach should also be used when considering replacing a faulty valve with either a mechanical or tissue valve.

In addition, among patients undergoing aortic or mitral valve replacement, the age range was expanded from 60 to 70 years of age to 50 to 70 years of age for the choice of either a mechanical or tissue valve. Mechanical were previously recommended for patients younger than 60 years old.

The authors have also clarified the previous recommendations regarding which patients with a risk of developing infective endocarditis should receive antibiotics before certain dental procedures. The guidelines now say that giving antibiotics to prevent bacterial infection is reasonable before dental procedures for people who have had previous valve surgery or previous infection of their valve or for patients who have certain types of congenital heart disease and were born with abnormal valves.

TEN POINTS to remember
http://www.acc.org/latest-in-cardiology/ten-points-to-remember/2017/03/14/18/26/2017-aha-acc-focused-update-of-valvular-heart-disease