Source: Siyu MedTech; Editor: Sophia
Reprint requirements: Can be reprinted 24 hours after the first publication, source must be credited.
Recently, Edwards Lifesciences (NYSE: EW), a cardiovascular giant, announced that it has signed multiple agreements related to structural heart disease products with the French company Affluent Medical. The agreements cover Affluent Medical'sKalios Adjustable Mitral Annuloplasty Ring and Related Mitral Valve Technologies。
According to the agreement, Affluent Medical will receive$16.3 million (approximately 120 million RMB)The prepayment is considered a cash payment.
In the agreement, Edwards Life Sciences is willing to pay 5.44 million US dollars (5 million euros) to acquire Affluent Medical.Exclusive Purchase Right of Subsidiary KephaliosThe company has products related to kalios; Affluent Medical intends to continue exclusive management and development throughout the lifecycle of the option.
Kalios Artificial Mitral Valve Annuloplasty RingIn addition, for 5 million euros, obtainGlobal Non-Exclusive License for Affluent Medical Intellectual Property (IP) Related to Bionic Heart Mitral Valve Replacement Technology，May include future royalties on all potential commercial products involving the use of licensed patents.
Affluent Medical retains all patent rights for its transcatheter valves, including theirEpygon Mitral Valve；
And further invested 5 million euros to acquire 9.21% of Affluent Medical's shares.
Following the announcement, shares of Affluent Medical rose 23.13% on the Paris Stock Exchange this Friday.# kAlios Artificial Mitral Valve Annuloplasty RingKalios is an artificial mitral valve annuloplasty ring currently under clinical investigation.Unlike traditional mitral valve annuloplasty rings, after implantation, at any time,The annulus size can be repeatedly adjusted percutaneously to meet the actual needs of patients without stopping the heart., thereby avoiding the need for a second surgery.Kalios consists of "Configuration at implants" and "Kalios fit" two parts.Configuration at implantsIncluding a lead (thin tube) that is implanted in the patient's body, with its distal end accessible via a subclavicular port, facilitating access to devices such as pacemakers;Kalios fitConsists of three balloon catheters and three connecting tubes.- During implantation, the distal end of the connecting wire is connected to the subclavicular position.
- If residual regurgitation occurs, the septal spindle is retracted through the connecting line from the hollow structure of the ring.
- The triballong catheter is then inserted from the distal end of the connecting line into position and gradually inflated in up to three predefined anatomical regions (referred to as P1, P2, and P3) to bring the valve leaflets closer together.The adjustment is performed under echocardiographic guidance in areas of insufficient contact, including repositioning the annulus to the desired level to eliminate residual regurgitation.
- By comprehensively adjusting all three regions (P1, P2, and P3), the maximum reduction in valve orifice area is limited to approximately 15% to prevent any risk of valve stenosis.
- The distal end of the connecting line is retrieved from the subcutaneous position in the subclavicular region; the spacer mandrel is removed, and a triple-balloon catheter is introduced. Adjustment is then performed through the same procedure as the perioperative adjustment.
The adjustment of the Kalios™ annuloplasty device can be repeated postoperatively until the maximum dilation of the P1, P2, and P3 regions.# Epygon——The First "Physiological" Mitral Bioprosthetic ValveEpygon is the first "physiological" mitral bioprosthetic valve that can restore the natural blood vortex in the left ventricle, promoting the recovery of ventricular function, especially for fragile patients with severely compromised cardiac conditions.The human mitral valve is naturally asymmetrical, generating rotational flow or vortices within the ventricle to minimize energy loss and help direct blood flow straight into the aortic outflow tract.Epygon The unique design includes the combination ofSingle leaf of pericardial tissue in D-ring。Asymmetric nitinol frames and physiological anchoring systems ensure stable coupling below the mitral valve annulus, capture native valve leaflets, and achieve optimal fit with low risk of LVOT obstruction.After inserting the guidewire through the apex, the Epygon delivery system can use fluoroscopy and echo guidance to ensure optimal central positioning within the native mitral valve.In the first stage, the atrial part of the device is gradually released just above the annular plane. In the 3D echo view, the atrial lobe of the valve stent unfolds to achieve the desired D-shaped rotational position.Under rapid pacing, the valve is now gently pulled towards the mitral valve annulus.Then, the ventricular anchoring system of the stent is released below the annulus, while the two clamping arms capture the posterior and anterior leaflets to prevent LVOT obstruction.Epygon Transcatheter Mitral Valve Prosthesis can restore physiological blood flow within the ventricle while keeping the native leaflets/chordae tendineae in traction to better preserve left ventricular function.# Divestment of Intensive Care BusinessIn June 2024, Edwards Lifesciences announced that it had reached a definitive agreement with BD Medical to transfer its entire line of critical care products.Sold to BD Medical for $4.2 billion in cash。Based on this agreement, Edwards will no longer proceed with the previously announced plan to spin off its critical care business.
Edwards will use the post-tax cash proceeds to support subsequent strategic growth needs. This sale enhances the flexibility of Edwards' balance sheet, allowing it toTreatment Techniques for Patients with Aortic Valve, Mitral Valve, Tricuspid Valve, and Pulmonary Valve Diseases, and Interventional Treatment for Heart Failurein new treatment areas for orderly investment.
Edward Life Sciences CEO Bernard Zovighian stated:
"The fundamental reasons for Edwards' divestiture of its critical care business remain unchanged——We will focus on pursuing a strategy centered on structural heart disease.Our goal is to serve a large number of unmet patient needs through differentiated innovation.At the same time, further expand the company's leadership position globally, achieve sustainable growth, and increase shareholder value.
We believe this transaction will further solidify Edwards, Critical Care, and BD Medical's positions in the industry, strengthening the business foundations of both companies and committing to deliver greater value to patients."
The transaction is expected to be completed by the end of 2024, subject to the satisfaction or waiver of certain closing conditions, including obtaining the necessary approvals for antitrust and foreign investment permits.
# Affluent MedicalOther ProductsAffluent Medical, established in 2011, focuses on developing innovative minimally invasive implants, primarily targeting cardiovascular diseases and urinary incontinence.
In addition to the two products mentioned above, the company has two other products worth knowing about.Kardiozis——AAA Stent Graft with Fuzz
Kardiozis Containing external thrombogenic fibers, these fibers induce blood clotting on their surface after being implanted in the human body, forming a thrombus that prevents the growth of the aneurysm sac and reduces the risk of endoleaks.
Kardiozis It is in a compressed state when implanted in the human body, reducing the difficulty of implantation.
After being placed in the correct location,Kardiozis It will be fully deployed and fixed on the aortic wall to prevent movement.
During use, it is important to note that the extension of the prosthesis must be implanted into the artery supplying blood to the lower limbs.
Kardiozis Delivery System
Artus——Artificial Urinary SphincterArtus is an artificial urinary sphincter for stress urinary incontinence, which can be implanted through minimally invasive surgery.After the surgery is completed, patients can use a remote control to open and close the artificial urinary sphincter based on their own condition.In order to better adapt to the human body, the structure and materials of Artus are designed with the standard of being permanently implantable.During the surgery, the doctor will place a silicone cuff around the urethra and secure it in position. Once the patient has adapted, the other end of the cuff will be connected to a remote control, allowing the patient to adjust the opening and closing of the cuff based on their physical condition and lifestyle.Affluent Medical, established in 2011, focuses on developing innovative minimally invasive implants, primarily targeting cardiovascular diseases and urinary incontinence.Currently, the four products under Affluent Medical—Kalios, Epygon, KARDIOZIS (an endovascular prosthesis for treating abdominal aortic aneurysms), and the Artus artificial urethral sphincter—are all in the preclinical and clinical research stages.In 2020, Affluent Medical announced the completion of a €15.8 million private placement financing round, led by Truffle Capital, with participation from Head Leader Limited (China), Ginko Invest, Fate, and Simone Merkle.At the same time, Jean-Francois Le Bigot from Ginko Invest and Benoit Adelus from Fate will join the company's board of directors.
Editor-in-Chief | Zhao Qing Reviewed by | Yi He
