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BioWorld - Friday, April 10, 2026
Home » Topics » Disease categories and therapies » Cardiovascular

Cardiovascular
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Chinabio 2025: Europe-China pharma deals rise as US markets shut

April 23, 2025
By Marian (YoonJee) Chu
Europe was a bigger counterpart to China in pharmaceutical dealmaking than the U.S. last year, speakers at Chinabio Partnering Forum said April 23, and the trend is likely to continue in 2025 with the shuttering of U.S. capital and volatility ailing global markets.
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FieldForce Catheter

Field Medical harvests $40M for PFA system

April 22, 2025
By Annette Boyle
Field Medical Inc. reaped $40 million in its series A fundraising via $20 million in new capital and conversion of $20 million in seed-round debt to support development of its next-generation pulsed field ablation technology. Field Medical’s Fieldforce ablation system targets ventricular tachycardia as its initial use, but also has a study in process for atrial fibrillation.
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Sky Labs CART BP

Sky Labs seeks global expansion of world’s first BP monitor ring

April 22, 2025
By Marian (YoonJee) Chu
Sky Labs Inc. CEO and founder Jack Byunghwan Lee reported on plans to greatly expand the market for the company’s blood pressure monitor ring, including seeking regulatory approvals for the CART BP products in the U.S., Europe and Japan.
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Map of Europe, Medical Device Regulation (MDR) text

Elixir granted CE mark for Lithix IVL

April 15, 2025
By Annette Boyle
Receipt of EU MDR CE mark may not be a magic potion, but Elixir Medical Corp. is certainly feeling a boost from the regulatory nod for its mechanical Lithix hertz contact intravascular lithotripsy system for treatment of moderate to severely calcified coronary artery lesions. Simultaneously, the company reported the launch of Lithix and completion of first cases in Italy, France and Germany.
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Sanofi advances asthma drug despite phase II miss

April 15, 2025
By Lee Landenberger
Despite missing a phase II study’s primary endpoint in moderate to severe asthma, Sanofi SA sees a way forward to a phase III program in the crowded disease space. Preliminary results showed the annualized exacerbation rate endpoint wasn’t met at the highest dosage of amlitelimab. Those numbers, at week 48, showed nominal significance at the medium dose.
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Edwards Lifesciences Sapien M3

Edwards lands first CE mark for transfemoral mitral valve replacement

April 14, 2025
By Annette Boyle
Edwards Lifesciences Corp.’s Sapien M3 secured CE mark for its Sapien M3 mitral valve replacement system for transfemoral treatment of patients with mitral valve disease who are ineligible for surgery or transcatheter edge-to-edge repair. Sapien M3 is indicated for individuals with symptomatic moderate-to-severe or severe mitral valve regurgitation.
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Illustration of TAVR device

CMS disinclined to reassign TAVR procedures to higher-paying DRG​

April 14, 2025
By Mark McCarty
The U.S. Medicare draft inpatient rule for fiscal 2026 discusses a number of coding proposals, although the agency seems disinclined to go along with a proposal to increase payment rates for TAVR devices by switching the procedures to a different diagnostic-related group.
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Illustration of human heart with DNA structure background

Early stage cardio data from Verve bump the stock

April 14, 2025
By Lee Landenberger
Positive early stage data for Verve Therapeutics Inc.’s base editing therapy points to a range of development options, including bringing partner Eli Lilly and Co. in a little closer. The new data helped ease the company’s pain from the April 2 enrollment pause of a similarly designed therapy from Verve. Verve’s Heart-2 phase Ib of VERVE-102 in treating 14 patients with heterozygous familial hypercholesterolemia and/or premature coronary artery disease showed one infusion led to dose-dependent decreases in blood PCSK9 protein levels and low density lipoprotein cholesterol.
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Heart illustration
Cardiovascular

CSPC’s SYH-2046 gains clinical trial clearance in China for heart failure

April 14, 2025
CSPC Pharmaceutical Group Ltd. has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for SYH-2046 for heart failure after acute myocardial infarction.
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David Luria Ziv Menshes

Cardiovia Viaone epicardial access system secures US FDA clearance

April 11, 2025
By Shani Alexander
Cardiovia Ltd.' Viaone epicardial access system received U.S. FDA clearance for treating cardiac arrhythmias. The device provides clinicians with a safe and minimally invasive technology to reach the heart’s outer surface, known as the pericardial space, without the need for a sharp needle, which can cause perforation.
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