First Patient Enrolled in Kaizen Clinical Study in Japan 

On January 11, 2023, Cardiovascular Systems, Inc., a medical device company developing and commercializing innovative interventional treatment systems for patients suffering from peripheral and coronary artery disease, announced the initiation of the KAIZEN clinical study of its Diamondback 360 Peripheral Orbital Atherectomy System (OAS) with the enrolment of the first patient in the trial in Japan. 

KAIZEN is a prospective, single-arm, multi-center study aimed at evaluating the safety and efficacy of the company’s Diamondback 360 Peripheral OAS in the treatment of de novo symptomatic calcified occlusive atherosclerotic lesions in the superficial femoral artery and popliteal artery. Up to 100 subjects at up to 12 study sites are expected to be enrolled in the study. 

The Diamondback 360 Peripheral OAS is used for the treatment of calcified plaque in patients with peripheral artery disease (PAD). It is a minimally invasive, single-use, catheter-based device capable of differentiating between hard, diseased plaque and healthy, compliant arterial tissue. The OAS orbiting crown reduces and modifies calcified plaque along with preserving the healthy vessel wall to restore blood flow. 

“We look forward to completing KAIZEN and working with the investigators and regulators so that we may offer peripheral OAS therapy to physicians in Japan,” said Scott R. Ward, CSI’s Chairman, President, and Chief Executive Officer. 

Tatsuya Nakama, M.D., Vice Director, Department of Cardiology, Tokyo Bay Urayasu Ichikawa Medical Center commented, “I felt that the Diamondback 360 Peripheral OAS offered both effective treatment and ease of use. I was able to observe significant vessel compliance change, which permitted satisfactory balloon expansion at low pressure. Additionally, I felt that minimal distal embolism compared to other devices throughout the procedure was greatly comforting. I look forward to further evaluation of the device, but believe it will be seen as a highly welcomed tool in the battle against calcified vessels.”

As per DelveInsight’s Peripheral Artery Disease Market” report, the global peripheral artery disease market was valued at USD 3,757.64 million in 2021 and is likely to register a CAGR of 6.64% during the forecast period from 2022 to 2027 to reach USD 5,469.02 million by 2027. The peripheral artery disease (PAD) market is observing remarkable market growth due to the factors such as the escalating burden of the geriatric population and the rising prevalence of PAD and arteriosclerosis across the globe. Furthermore, the rising prevalence of obesity, diabetes, and high blood pressure, coupled with increasing product launches, are creating positive market growth.

Enovis Launched DynaClip Delta™ and DynaClip Quattro™ bone staples 

On November 17, 2022, Enovis, an innovation-driven medical technology company announced the launch of DynaClip Delta™ and DynaClip Quattro™ bone staples expanding the company’s growing foot and ankle portfolio. 

The DynaClip Delta™ and DynaClip Quattro™ staples are designed to provide foot and ankle surgeons with ease of use and procedural efficiency in the operating room. The staples are pre-loaded on disposable inserters that allow quick deployment and accurate positioning of legs.

Without any compromise on durability and performance, these staples deliver faster and easier first metatarsophalangeal (MTP) fusion procedures. New data highlights that the DynaClip Delta Bone Fixation System has the stiffness of a traditional plate and lag screw construct, and the dynamic aspect of the staple greatly reduces permanent gapping. 

Based upon NiTiNOL technology, DynaClip Delta and DynaClip Quattro staples are designed to distribute stress across the staple bridge and help to achieve sustained dynamic compression across fusion sites.

Tyler Gonzalez, MD, MBA, a Foot & Ankle Surgeon in Lexington, South Carolina said, “I am a believer and user of NiTiNOL implants. The DynaClip Quattro NiTiNOL staple is a newly designed four-legged staple advancing the current design of NiTiNOL staples on the market,” said Tyler Gonzalez, MD, MBA, a Foot & Ankle Surgeon in Lexington, South Carolina.” He further added, “Using this newly designed four-legged staple has added a new tool to my armamentarium for surgical fixation. It has improved my efficiency and expanded my versatility in midfoot and hindfoot fusions.”

“Providing surgeons with cutting-edge solutions that improve both efficiency and outcomes for our customers and patients is the ’why’ behind everything we do,” commented Gary Justak, President and General Manager of Enovis Foot & Ankle. He further added, “Our customers have come to expect innovative, game-changing products from Enovis Foot & Ankle, and the introduction of the DynaClip Delta and Quattro staples is just another way that we are disrupting the market and elevating patient treatment options.”

According to DelveInsight’s “Foot and Ankle Devices Market” report, the global foot and ankle devices market was valued at USD 5.94 billion in 2021, growing at a CAGR of 7.69% during the forecast period from 2022 to 2027, to reach USD 9.26 billion by 2027. The foot and ankle devices market is estimated to register positive revenue growth primarily due to rising research and development activities, the increasing prevalence of bone disorders, the rising number of accident and trauma cases, and the rising number of sports-related activities, among others. According to DelveInsight analysis, in the product segment of the global foot and ankle devices market, the internal fixation devices category is expected to account for the prominent market share during the forecast period. Internal fixation devices are commonly used to correct bone deformities and fractures. Additionally, internal fixation promotes faster recovery, and shorter hospital stays enable patients to resume their daily activities quicker and reduces the chances of improper healing of broken bones.

Medcura’s LifeGel™ Absorbable Surgical Hemostat Received Breakthrough Device Designation

On January 12, 2023, Medcura, Inc., a medical device company dedicated to transformatively improving the management of surgical bleeding, received the Breakthrough Device Designation for its LifeGel™ Absorbable Surgical Hemostat from the US Food and Drug Administration (FDA). 

As the first and only hemostatic agent to receive Breakthrough Device Designation, LifeGel™ is used in surgical procedures (aside from ophthalmic and urological procedures) as an adjunctive hemostatic device when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical. LifeGel™ can be utilized in surgical operations when swelling cannot be tolerated because of its no-swell characteristics.

The patented and exclusive formulation of Medcura was created to not swell upon administration, hence removing the potential for spinal cord compression brought on by swellable hemostatic medications. LifeGel™ doesn’t include any human or animal proteins, including thrombin, unlike many other hemostatic medications, and it doesn’t need to be mixed beforehand or prepared for cold chain storage. 

LifeGel™ is ready to use, which assist can prevent costly delays, hazards, and difficulties related to uncontrolled bleeding and lessen the operating room’s waste of costly hemostatic supplies. These distinguishing qualities, together with the platform’s game-changing cost advantage, put Medcura’s LifeGel™ in a position to replace current standards of care for the control of surgical bleeding.

“We’re very pleased for the opportunity to continue working closely with the FDA to improve a surgeon’s ability to control and stop the wide range of bleeding scenarios for which the Breakthrough Designation was awarded,” commented Jim Buck, Medcura President, and CEO. He remarked, “This designation provides for a more collaborative partnership with the FDA which should expedite patient access to LifeGel as a game-changing new solution to surgical bleeding management.”

Medcura’s Chief Medical Officer, neurosurgeon Dr. Ken Renkens said, “Over the past decade, there have not been meaningful advancements in the safe control of surgical bleeding using flowable technologies which are routinely used in many high-volume and high-value procedures.” He further added, “With the experience, we’ve gained through extensive pre-clinical testing, LifeGel has shown to be easy and intuitive to use while demonstrating a remarkable ability to reliably control the wide range of challenging bleeding situations a surgeon often confronts.”

According to DelveInsight’s Hemostats Market” report, the global hemostats market was valued at USD 3.64 billion in 2021, growing at a CAGR of 5.72% during the forecast period from 2022 to 2027, to reach USD 5.07 billion by 2027. The increase in demand for hemostats is predominantly attributed to the increasing number of surgical procedures, the growing focus on blood loss management during surgeries, the emphasis on improving the safety and usability of hemostats for end-users, and growing technological advancements, among others. According to DelveInsight analysis, by the formulant segment, the matrix and gel category is projected to register significant growth in revenue in the hemostats market during the forecast period. This can be ascribed to the advantages associated with the matrix and gel substances. The matrix and gels are better biocompatibility and clotting characteristics when used during surgeries.

Koneksa Started a Clinical Trial for Evaluating At-Home Mobile Spirometry Using Digital Measures in Moderate Asthma

On January 17, 2023, Koneksa, a healthcare technology company developing evidence-based validated digital biomarkers, initiated a clinical study aimed at comparing the treatment effect between at-home mobile spirometry using digital biomarkers and in-clinic spirometry in patients with moderate asthma on long-acting beta-agonist (LABA) treatment.

The LEARN research is a single-arm interventional trial that compares at-home mobile spirometry utilizing an ultrasonic spirometer and a smartphone against in-clinic spirometry to detect therapy effects in people with mild asthma. Up to 60 people with moderate uncontrolled asthma who are currently using inhaled corticosteroids (ICS) but will need LABA therapy will be enrolled in the study, which will last six weeks.

Spirometry performed in a clinic can be performed at home with comparable or higher accuracy and perhaps less load on the patient. 

The study aims at evaluating the LABA treatment effect in the clinic and mobile spirometry and assesses the relationship between different readouts of mobile spirometry in addition to assessing asthma control as measured by ACQ-6, a patient-reported outcome questionnaire. The study will also evaluate patient and site-specific satisfaction with mobile spirometry technology.

“This study builds on Koneksa’s prior work demonstrating that mobile spirometry has the potential to detect clinically meaningful changes in very small cohorts of asthma patients on standard of care,” commented Chris Benko, CEO & Founder of Koneksa. He further added, “The LEARN study will evaluate whether at-home mobile spirometry can detect treatment effects of a known positive control (LABA) in a significantly smaller population than would traditionally be assumed for an in-clinic proof-of-concept study.”

John A. Wagner, Chief Medical Officer, Koneksa said, “More frequent at-home mobile spirometry measurements are expected to be more sensitive and accurate and may provide earlier detection of treatment effect in a smaller sample size when compared with in-clinic spirometry.” He remarked, “We look forward to providing updates from the LEARN study, to evaluate whether digital biomarkers derived from remote monitoring with a smart device and mobile spirometer can provide additional information correlated to symptom scores in asthma.”

According to DelveInsight’s Spirometers Market” report, the global spirometers market was valued at USD 1,357.83 million in 2021 and is likely to register a CAGR of 4.65% during the forecast period from 2022 to 2027 to reach USD 1,801.66 million by 2027. Some of the major factors driving the spirometer market growth are increasing technological advancement, a rise in the burden of COPD, and an increasing prevalence of respiratory disorders, among others. Moreover, numerous spirometers in development with the scope of entering the market in the coming years are further expected to present a favorable market environment for the spirometers market during the forecast period.

Abbott Received FDA Clearance for NAVITOR

On January 17, 2023, Abbott announced the US Food and Drug Administration (FDA) clearance for the company’s latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor™, expanding the company’s comprehensive transcatheter structural heart portfolio that offers minimally invasive treatment options to physicians and patients for some of the most common and serious heart diseases.

Navitor™ is intended for treating people with severe aortic stenosis who are at high or extreme risk for open-heart surgery. The Navitor™ has a special fabric cuff (NaviSeal) to lessen or stop the paravalvular leak, or the backflow of blood around the valve frame (PVL). 

The innovative device is also the only self-expanding TAVI system with leaflets within the native valve; this design can aid in facilitating future procedures for treating coronary artery disease by making it easier to reach coronary arteries. Excellent hemodynamics, or blood flow, is provided by the system through the valve. Abbott’s FlexNavTM delivery system, which has a narrow design to suit various patient anatomy and small vessels for stable, predictable, and accurate valve delivery and placement, is used to implant the Navitor™ device.

“Our Navitor valve builds upon our industry-leading portfolio of minimally invasive devices that surpass existing standards of care to address a range of heart diseases,” said Michael Dale, senior vice president of Abbott’s structural heart business. He commented, “Navitor is the first TAVI system to offer optimal hemodynamics in all valve sizes while also preserving options for lifetime disease management, an important consideration for physicians and patients when selecting a TAVI solution. Receiving this approval is a major next step in our mission to help people live better lives through better health.” 

Michael Reardon, M.D., Alison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital commented, “Abbott’s Navitor device features advancements to help doctors safely and effectively treat patients with aortic stenosis, including a design that reduces the backflow of blood around the valve that’s often a complication following TAVI procedures.” He further said, “The innovative Navitor system also offers physicians stable and accurate device placement, even in challenging patient anatomies.” 

According to DelveInsight’s Transcatheter Aortic Valve Replacement Market” report, the transcatheter aortic valve replacement market was valued at USD 3.23 billion in 2021, growing at a CAGR of 15.41% during the forecast period from 2022 to 2027 to reach USD 7.64 billion by 2027. The demand for transcatheter aortic valve replacement is primarily attributed to the growing burden of cardiovascular diseases, increasing prevalence of aortic stenosis disorder, rising cases of aortic regurgitation, and the technological advancements in the transcatheter aortic valve replacement arena, among others, during the forecast period. According to DelveInsight analysis, among all the regions, North America is expected to account for the significant market revenue share in the transcatheter aortic valve replacement devices market owing to the increasing number of aortic stenosis, and aortic regurgitation cases, rising prevalence of cardiovascular diseases, rise in transcatheter aortic valve replacement device approvals and launches, and their expansion in newer indications are the key factor contributing to the transcatheter aortic valve replacement devices market in the country. 

Bausch + Lomb Acquired AcuFocus, Inc.

On January 17, 2023, Bausch & Lomb, a leading global eye health company dedicated to helping people see better to live better, announced that an affiliate of Bausch + Lomb has acquired AcuFocus, Inc., a privately held ophthalmic medical device company known for delivering breakthrough small aperture intraocular products to address diverse unmet needs in eye care and help patients achieve their best personal vision.

The acquisition of AcuFocus, Inc. is going to enhance Bausch + Lomb’s Surgical Portfolio with IC-8 Apthera™ Intraocular Lens. 

The IC-8 AptheraTM intraocular lens (IOL) was approved by the US FDA in July 2022 as the first and only small aperture non-toric extended depth of focus (EDOF) IOL for specific cataract patients who have as much as 1.5 diopters of corneal astigmatism and wish to address presbyopia at the same time. AcuFocus has developed ground-breaking small aperture intraocular technology to address the diverse unmet needs in eye care. In international markets, this IOL is referred to as the IC-8 IOL and is offered in a few markets in Europe, as well as in Australia, New Zealand, and Singapore.

“Cataracts are the largest contributor to global blindness in adults aged 50 years and older, with more than 15 million individuals, or approximately 45 percent of the more than 33 million cases of global blindness.5 We believe that the IC-8 Apthera EDOF IOL will bolster our surgical portfolio by enhancing our IOL offerings, which is a strategic area of focus for Bausch + Lomb,” commented Joseph C. Papa, CEO, of Bausch + Lomb. He further mentioned, “We will continue to focus on areas of unmet medical need that we believe will help drive long-term growth in our core segments, and importantly, help us achieve our mission of helping people see better to live better.”

Al Waterhouse, president, of and CEO, AcuFocus commented, “Bausch + Lomb is a legacy name in eye care with a fully integrated portfolio of offerings in eye health.” He remarked, “With its extensive development footprint and renowned commercial expertise, we believe Bausch + Lomb is best positioned to educate physicians about the IC-8 Apthera lens, and ultimately, ensure more cataract patients have access to this new IOL.”According to DelveInsight’s “Intraocular Lens Market” report, the global intraocular lens market was valued at USD 3.85 billion in 2021 and will grow at a CAGR of 4.89% during the forecast period from 2021 to 2026 to reach USD 5.13 billion by 2027. Some of the key factors driving the growth of the global intraocular lens market are the rising prevalence of eye diseases such as refractive errors, age-related macular degeneration, cataract, diabetic retinopathy, and glaucoma. Increasing the number of cataract surgeries is further driving the demand for IOLs, growing capital investment in research and development for technologically advanced products, and launching several government initiatives for cataract elimination are also key factors. According to DelveInsight analysis, among all the regions, Asia-Pacific is expected to account for the fastest growth in terms of CAGR, with 5.90% in the intraocular lens market. This can be attributed to the increasing prevalence of ocular diseases, rising investments, and big collaborative expansions by key regional players.