Cardiac Care Device Manufacturer in India
Heart devices used in the cath lab face some of the strictest rules in medical equipment, and for good reason. Here is who makes them in India, and what to check before your cath lab picks a supplier.
Who manufactures cardiac care devices in India? India's cardiac care device manufacturers include Meril Life Sciences and horizontal OEMs such as Pulse. Between them, they produce coronary stents, PTCA balloons, guidewires, sheaths, and cath lab accessories. Each manufacturer should be verified individually against their CDSCO licence and certification before purchase.
What Counts as Cardiac Care Equipment
This group covers the devices used in the cath lab to open and treat heart arteries. It includes:
- Drug-eluting coronary stents (sirolimus, everolimus)
- Inflation device kits and manifolds
- Guidewires
- Vascular access needles
- Sheath kits that give safe access to a vein or artery
Stents and other devices that stay in the body are usually in CDSCO's top risk group, Class D. So proof from trials and proof of good factory quality matter more here than for almost any other kind of equipment.
Who Makes Cardiac Care Equipment in India
Check each company's range with them before you buy. The table shows the market as it stood when we wrote this.
| Company | Cardiac Care Relevance |
|---|---|
| Meril Life Sciences | Stents, balloons, heart valve products and other cath lab devices |
| Pulse | Makes stents, inflation kits, manifolds, guidewires and access kits |
Need a price for your hospital or clinic?Get a written quote, brochure or demo from the Pulse team.
Why This Category Demands Extra Scrutiny
A stent stays in the patient for life. If it fails, the harm is direct and lasting. Unlike a monitor or a ventilator, you cannot swap a stent for another brand halfway through a case. So trial data, strut design and how firmly the stent holds on the balloon really matter. These are not sales points. Your heart doctors should read them before a stent is added to your cath lab list.
What to Verify Before Buying
- CDSCO licence and risk class (most cath lab devices are Class C or D)
- Trial or test data, above all for stents and other devices left in the body
- Proof that the device is sterile and safe for body contact
- ISO 13485 certificate, and which plant and products it covers
- Who will support your team in the cath lab during cases
- How each batch is tracked, and how a recall would work
For implantable cardiac devices, ask for the clinical evidence before you ask for the price. Here, the cheaper choice is not always the safe one.
Pulse's Cardiac Care Product Range
Pulse makes these cardiac care products:
| Product | What It's For |
|---|---|
| Optima Inflation Device Kit | Kit to inflate the balloon, with a valve to stop bleeding, a wire insert tool and a torque device |
| Optima Manifolds | Low and high pressure manifolds with a 2.3mm lumen for high flow. Sterile and latex-free |
| AcuSafe Blunt Needle System | Sharp and blunt needles for safe, controlled access when draining fluid through the skin |
| Sirova Sirolimus Stent | Drug-coated stent (sirolimus) that bends easily through twisted heart arteries |
| EvroSure Everolimus Stent | Cobalt chromium everolimus stent with thin 59 µm struts |
| MedSure Sirolimus Stent | Cobalt chromium sirolimus stent with open cells for side branches |
| Glider PTCA Balloons | Angioplasty balloons in SC, NC and CTO versions |
| Mamba Drug-Coated Balloon | Sirolimus-coated balloon that treats the artery without a stent |
| Evera Everolimus Stent | Drug-coated stent (everolimus) that holds firmly on the balloon on the way to the blockage |
| GuideX Guidewires | Amplatz wire that is stiff and strong enough to guide a catheter, yet gentle on vessels |
| AcuSafe Micro-Access Kits | Small puncture set and valved sheath kit with a 21G needle and 0.018 wire |
| AcuSafe Introducer Kits for Venous Access | Sheaths and dilators for safe access when placing a central line |
As with any maker, check each Pulse product's CDSCO class and licence before you buy.
Cardiac Care Device Manufacturer in India: Key Facts
- Cardiac care devices include coronary stents, guidewires, inflation kits, manifolds, access needles and introducer kits.
- Coronary stents and other implantable devices usually fall in CDSCO's highest risk tier, Class D.
- From 1 April 2026, the NPPA ceiling price for a drug-eluting stent is Rs 39,186.03 plus GST.
- State Licensing Authorities license Class A and B manufacturing; the Central Licensing Authority regulates Class C and D.
- Pulse offers four drug-eluting stents (Evera, EvroSure, Sirova and MedSure) and PTCA balloons (Glider SC, NC, CTO and the Mamba drug-coated balloon).
Cardiac Care Device Manufacturer in India: FAQs
Who manufactures cardiac care devices in India?
India's cardiac care device manufacturers include Meril Life Sciences and horizontal OEMs such as Pulse. Between them, they produce coronary stents, PTCA balloons, guidewires, sheaths, and cath lab accessories. Each manufacturer should be verified individually against their CDSCO licence and certification before purchase.
What cardiac care devices are manufactured in India?
Indian manufacturers produce drug-eluting coronary stents, inflation device kits, manifolds, guidewires, vascular access needles, and introducer/sheath kits used in interventional cardiology and cath lab procedures.
What should a hospital check before buying cardiac devices from an Indian manufacturer?
Check the device's CDSCO risk classification (most interventional cardiac devices are Class C or D), the manufacturer's current licence, clinical evidence for stents and implantable devices, sterility and biocompatibility documentation, and cath lab technical support availability.
Sources
- Ministry of Health notifies Medical Device Rules 2017: 5 major takeaways (Medical Dialogues, February 2017): risk classes A to D and who licenses them
- NPPA revises coronary stent prices from April 2026 (Medical Dialogues, April 2026)
- ISO 13485:2016 Medical devices: Quality management systems (International Organization for Standardization)
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