Abbott receives CE Mark for Navitor™, the Latest-Generation Transcatheter Aortic Valve Implantation (TAVI) System for Aortic Stenosis treatment
On May 17, 2021, Abbott received CE Mark for its latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor™. This marks the minimally invasive device availability in Europe for patients with severe aortic stenosis having high or extreme surgical risk.
The company is advancing TAVI therapies with its Navitor valve that offers physicians and patients less invasive options to treat heart diseases using Abbott’s industry-leading FlexNav™ delivery system. The Navitor device is implanted with Abbott’s FlexNav delivery system, which obtained CE Mark in 2020. It offers a slim design with the lowest TAVI delivery system profile, allowing the treatment of people with vessels as tiny as 5.0 mm.
Michael Dale, senior vice president of Abbott’s structural heart business, said in a statement that the innovative design of the Navitor valve paired with the FlexNav delivery system streamlines and simplifies TAVI procedures for physicians, allowing better valve placement and performance for patients so they can get back to living fuller, healthier lives. This approval strengthens their structural heart portfolio of minimally invasive offerings by providing new options and improvements to treat a life-threatening heart condition.
SIRONA, the world’s first and largest RCT comparing Sirolimus V/S Paclitaxel balloon for the treatment of Peripheral Arterial Disease, progresses rapidly
On May 24 2021, Concept Medical Inc. focused on vascular intervention drug delivery devices, updated the status of SIRONA Randomized Control Trial (RCT), which compares head-to-head, Sirolimus versus Paclitaxel Drug-Eluting Balloon Angioplasty in femoropopliteal arterial diseases (SIRONA).
It is the world’s first RCT investigating the use of Sirolimus drug-coated balloon (DCB) (MagicTouch PTA – Concept Medical) V/S Paclitaxel DCB for the femoropopliteal artery disease treatment.
SIRONA is an Investigator-Initiated and driven, prospective, multi-centre, core lab adjudicated randomised trial to compare and assess the safety and efficacy of Sirolimus Coated balloon versus Paclitaxel Coated Balloon (CE certified devices) in the treatment of stenosed or occluded lesions in the superficial femoral artery (SFA), and/or popliteal artery (P1) in Peripheral Arterial Disease patients. The study will enrol a total of 478 patients randomised 1:1 (MagicTouch PTA:Paclitaxel Coated Balloon) across 30 sites in Germany and Austria and will be led by the Principal Investigator Prof. Dr. Ulf Teichgräber of Jena University Hospital, Germany; the study is rushing with 20 patients already enrolled.
GC Aesthetics® introduces the next generation of breast implants to market
On May 25 2021, GC Aesthetics, Inc. has launched its next generation of breast implants, PERLE ™. It is a highly innovative line of smooth breast implants featuring BioQ ™, proprietary surface technology, GCA’s industry-leading gel technology (Emunomic ™ Breast Tissue Dynamic Gel) and an improved version of the safety features that have underpinned GCA’s longstanding excellent safety record.
PERLE ™ will initially be launched in European markets and other markets worldwide to follow in the coming months.
CooperVision DreamLite® Ortho-K Lenses receives European Approval for slowing progression of Myopia
On May 25 2021, CooperVision Specialty EyeCare’s Procornea DreamLite® night lenses obtained European approval for decreasing the progression of myopia in children and young adults. DreamLite® night lenses can be utilised for myopia control with children who have refraction of -0.75 D to -5.00 D and cylindrical refraction with a maximum of -2.50 D.
This is the latest CooperVision myopia control product to gain the CE Mark, joining EyeDream and Paragon CRT® ortho-k designs, MiSight® 1 day soft contact lenses, and SightGlass Vision Diffusion Optics Technology spectacle lenses. The company has the world’s most extensive portfolio of evidence-based myopia control interventions.
Dr. Juan Carlos Aragón, President, CooperVision Specialty EyeCare, told in a statement that their commitments to innovations such as DreamLite® night lenses, providing broader access to optical interventions with scientifically demonstrated outcomes, and investing in widespread education for eye care professionals and parents are examples of why CooperVision continues to lead the myopia management category. The latest CE Mark will help ECPs communicate with even more confidence about DreamLite® lenses’ ability to slow the progression of myopia.
BD introduces Industry-First Ready-to-Use Iodine-Based Surgical Irrigation System
On May 25 2021, Becton, Dickinson and Company (BD) declared the availability of BD Surgiphor™ Sterile Wound Irrigation System, the first and only ready-to-use aqueous povidone-iodine (PVP-I) irrigation solution that mechanically frees and eliminates wound debris. It can help hospitals meet best practices set forth by U.S. health agencies, including the Joint Commission’s 2020 national patient safety goals. BD acquired BD Surgiphor™ from Orthophor, LLC in November 2020.
Kevin Kelly, worldwide president of Surgery for BD, informed that BD Surgiphor proffers hospitals with a ready-made solution for wound irrigation, launching a new tool in the sterile field that is labelled, effective, and simple to use during a procedure. The launch of BD Surgiphor will bring more simplicity to the sterile field and meet best practices established by the U.S. and global health agencies. The availability of BD Surgiphor™ moves BD Surgery’s portfolio beyond the current focus of surgical site skin prep and into intraoperative solutions. They also believe BD is well-positioned to continue growing its presence in the surgical setting.
Procyrion declares successful First-in-Human Cases in Cardiorenal Syndrome patients with Aortix™ Percutaneous Mechanical Circulatory Support Device
On May 25 2021, Procyrion, Inc. announced the successful treatment of the first patients in the company’s pilot trial to assess the performance of its novel Aortix™ percutaneous mechanical circulatory support (pMCS) device in cardiorenal syndrome (CRS) patients. The company is focused on improving outcomes for patients with cardiac and renal impairment and has begun its pilot trial in Australia and expanded to the U.S. after obtaining Investigational Device Exemption (IDE) approval in April from the U.S. Food and Drug Administration (FDA).
Dr. Jennifer Cowger, Medical Director of the Mechanical Circulatory Support Program and Co-Director of the Cardiac Intensive Care Unit at Henry Ford Hospital in Detroit, MI, said that they are thrilled to be the first centre in the U.S. to treat CRS patients with the Aortix device. The procedure was performed safely and efficiently due to the pump’s position in the aorta versus the heart, which enabled the rapid deployment of the catheter-based pump and significantly reduced the risk of stroke and damage to the heart. After finishing therapy, the patient showed significant improvement in the key hemodynamic parameters, shed over 10 litres of excess fluid, and significantly improved creatinine levels, a measure of kidney function.
SoftWave Tissue Regeneration Technologies patented Extracorporeal Shock Wave Device, the OrthGold 100®
On May 19 2021, SoftWave Tissue Regeneration Technologies patented extracorporeal shock wave device, the OrthGold 100®, which received FDA clearance on May 4, 2021, for the indications of a temporary rise in local blood circulation, relief of minor aches and pains, and connective tissue activation.
According to John Warlick, CEO of SoftWave TRT, this revolutionises the way pain is treated in a therapeutic setting. With a company focus on innovation, adding more licenses, and contributing to their pipeline of future clearances and approvals, they believe SoftWave TRT is positioned to provide the best shock wave technology and be the leader in this increasing segment of medical technology.
SoftWave TRT has approval from the FDA to treat superficial, partial-thickness, second-degree burns in adults, and the treatment of Diabetic Foot Ulcers (DFUs).
TricValve® Transcatheter Bicaval Valves System obtains CE Mark
On May 20 2021, OrbusNeich® Medical Company Ltd. and P&F Products & Features®, under the joint partnership OrbusNeich P&F, received CE mark approval for the TricValve® Transcatheter Bicaval Valves System.
This is developed to treat caval reflux present in severe tricuspid regurgitation cases without removing the defective tricuspid valve and is available in different diameters for each model (SVC and IVC) designed to adapt to the anatomic features of the superior and inferior vena cava.
Both the companies, OrbusNeich and P&F, have agreed to the exclusive distribution and manufacturing of a range of innovative minimally invasive heart valve products in the Asia Pacific region in November 2020.
CUREXO’s spinal surgery robot, ‘CUVIS-spine’ received FDA clearance
On May 20, 2021, CUREXO Corp., the Medical robot specialist company, received FDA approval for their independently developed spinal surgery robot ‘CUVIS-spine‘.
This is followed by Korea (2019) and Europe CE (2020) certificate and is the third license that the company have acquired. CUREXO plans to expand their focus on global markets, including the US and Europe.
Mr Jae-Joon Lee, CEO of CUREXO, said that the spinal surgery robot ‘CUVIS-spine’ that they have developed and manufactured with their technology has acquired FDA (US)’s licensing. This is the 3rd license they have acquired, followed by Korea and Europe, and now they can sell the solution in all countries, including the US, which is the most significant medical market. Moreover, he also added that CUREXO plans to focus on the medical robots sales, including ‘CUVIS-joint’, ‘CUVIS-spine’ and ‘Morning Walk‘ to the Korean market and advanced medical markets (the US and Europe).
EndoFresh received FDA 510(k) Clearance for its ground-breaking Disposable Digestive Endoscopy System
On May 24, 2021, EndoFresh Disposable Digestive Endoscopy System has received FDA approval for its endoscopy system, which features a camera system with innovative all-in-one design, disposable upper GI endoscope and disposable colonoscope, and are used together with the medical display and other peripheral devices to allow physicians to visualise, diagnose and operate gastrointestinal endoscopy.
According to Dr. Lee, EndoFresh CEO, medical practitioners, with this novel system, could offer patients a secure experience available at any time and anywhere. It helps to prohibit the risk of cross-infection and minimise the workload in preoperative screening and postoperative disinfection.
The global flexible endoscope market is blossoming for safety and effectiveness; many manufacturers have engaged in the R&D of the disposable endoscope. The company addresses the traditional challenge of expanding endoscopy procedures while ensuring its single-use devices are cost-effective, risk-controllable and accessible.
Boston Scientific receives CE Mark for EXALT™ Model B Disposable Bronchoscope
On May 25 2021, Boston Scientific Corporation has obtained a CE mark for the EXALT ™ Model B Single-Use Bronchoscope, a single-use device designed for procedural performed at the bedside in the intensive care unit, in the operating room and in the bronchoscopy. The company will begin the marketing of the device in Europe in the coming weeks.
The EXALT Model B Bronchoscope will be proffered in three sizes – Small, Normal and Large – for various bronchoscopy procedures such as secretion management, airway intubation, percutaneous tracheostomy, endotracheal tube placement double lumen and biopsies.
Professor Kaid Darwiche, Head of the Interventional Respiratory Department at the Ruhrlandklinik in Germany, said that since single-use bronchoscopes are relatively new, there is a need for constant innovation so that physicians can directly and precisely visualise the lungs and airways of patients. The EXALT Model B Bronchoscope offers a clear, crisp image and high-power suction, two essentials in successfully recognising any abnormalities in the patient’s airways.
Dave Pierce, executive vice president and president of MedSurg and president of Endoscopy, Boston Scientific, said that single-use endoscopes are becoming the preference of many physicians due to their ability to remove the risk of infection associated with endoscopes that can lead to inefficient reprocessing while increasing operational efficiency in the hospital environment. Innovation is at the heart of their mission, and the EXALT Model B Bronchoscope is designed to provide physicians with high-quality functionality and the feel of a reusable endoscope while meeting increased patient safety needs and improving efficiency.
Micro Interventional Devices, Inc. received Breakthrough Device Designation from FDA for the MIA™-T Percutaneous Tricuspid Annuloplasty System
On May 27 2021, The U.S. Food and Drug Administration (FDA) granted Micro Interventional Devices (MID) a Breakthrough Device Designation for its MIA™-T Percutaneous Tricuspid Annuloplasty System, used to treat moderate-severe tricuspid regurgitation (TR) via a 12F catheter-based system. This addresses the unmet needs in the treatment of structural heart disease.
The safety and performance of MIA-T have been shown in the STTAR, Study of Transcatheter Tricuspid Annular Repair, conducted at 6 European clinical sites. The encouraging 12-month follow-up data was submitted for CE Mark approval in December 2020. The company anticipates receiving CE Mark approval and IDE approval to initiate the STTAR-US pivotal study by the end of 2021.
Michael Whitman, President and CEO of MID, said that the relative simplicity, safety and security of the MIA-T system would help many patients suffering from moderate-severe tricuspid regurgitation in the United States. They expect that breakthrough device designation will speed the process to commercialisation so patients, physicians and the healthcare system can profit from this technology.
Varian secures FDA “Breakthrough Device Designation” for its Cardiac Radioablation (CRA) System for the treatment of Refractory Ventricular Tachycardia (VT)
On May 26 2021, the U.S. Food and Drug Administration (FDA) granted Varian, a Siemens Healthineers company, a Breakthrough Device Designation for its cardiac radioablation (CRA) system, currently in development as a non-invasive therapy for select patients with refractory ventricular tachycardia (VT).
Varian’s CRA system was designated a Breakthrough Device by the FDA due to its potential to proffer a more effective treatment for select patients with refractory VT.
Kolleen Kennedy, President, Proton Solutions and Growth Office, Varian, told in a statement, the early positive clinical results hints that non-invasive cardiac radioablation could offer new hope for patients with refractory VT. They look forward to developing this important new technology and working closely with the FDA to develop the appropriate clinical program for market approval.
FH ORTHO announces the first case using e-ORTHO Shoulder Software
On May 27 2021, Olympus Corporation competed for a first use case of the 510(k) cleared e-ORTHO Shoulder software developed by FH ORTHO, a company that Olympus purchased in November 2020. The case, conducted by Brian Schofield, MD, was an Arrow Prime shoulder replacement in which the next generation e-ORTHO 3D planning software was utilised for preoperative surgical technique planning.
Dr. Schofield of Schofield, Hand and Bright Orthopedics, Sarasota, Fl said they believe that this case may have saved OR time because of their pre-operative planning with e-ORTHO. They look forward to continuing use of the e-ORTHO system, which helps with optimising glenoid adjustment, assists in adapting to the unique anatomical features of each patient, and could help a surgeon visualise a potential complication pre-operatively while allowing for contingency planning to address potential complications.
In October 2020, the FH ORTHO received 510(k) clearance for its e-ORTHO planning software, saving OR time by allowing physicians to plan their surgical technique more efficiently. The web-based e-ORTHO platform uses CT scans of the entire scapula to construct a 3-D model of the anatomy to assist in preoperative surgical technique planning without the need for costly custom instruments often associated with software planning systems.